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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC

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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® PLUS BIOMATERIAL; MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMCP08
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Seroma (2069)
Event Date 07/06/2015
Event Type  Injury  
Event Description
It was reported to gore that the patient underwent laparoscopic ventral incisional hernia repair on (b)(6) 2009 whereby a gore® dualmesh® plus biomaterial was implanted.The complaint alleges that on (b)(6) 2015, an additional procedure occurred whereby the gore device was explanted.It was reported the patient alleges the following injuries: chronic pain/discomfort, seroma, thick seroma cavity involving the mesh entirely, omentum completely stuck involving the cavity of the seroma, omentectomy, abdominal reconstruction, infection, multiple loculated fluid collections, reticulation of the subcutaneous tissues, recurrent posterior mesh seroma, resection of 80 percent of the seroma capsule, left groin seroma, adhesions.Additional event specific information was not provided.
 
Manufacturer Narrative
The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].It should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence." the gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.".
 
Manufacturer Narrative
H6: updated investigation findings code.Conclusion remains unchanged it should be noted that the gore® dualmesh® plus biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.If an infection develops, it should be treated aggressively.An unresolved infection may require removal of the material.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
 
Manufacturer Narrative
B7: added medical history.H6: updated health effect - impact codes.Conclusion code remains unchanged.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: (b)(6), 2008:(b)(6)inpatient hospitalization (b)(6) 2008: (b)(6), md.Operative report.Assistant #1: (b)(6) md.Assistant #2: (b)(6), md.Assistant #3: (b)(6), md.Assistant #4: (b)(6), md.Procedure: 1.Total abdominal hysterectomy, bilateral salpingo-oophorectomy.2.Lymph node dissection.3.Umbilical hernia repair.Preoperative diagnosis: 1.Endometrial cancer.2.Umbilical hernia.Postoperative diagnosis: 1.Endometrial cancer.2.Umbilical hernia.Anesthesia: general.Estimated blood loss: ¿approximately 200 ml¿s.¿ specimens: ¿pathology specimens include uterus, cervix, ovaries and tubes, lymph nodes from the right and left common iliac, external iliac and obturator nodes.¿ complications: none.Indications: ¿the patient is a (b)(6) postmenopausal female with a history of vaginal bleeding.The patient had a dilatation and curettage performed (b)(6), 2008 which showed endometrial cancer grade i.The patient was consented after being informed of the risks of hemorrhage, infection, damage to internal organs for a total abdominal hysterectomy and bilateral salpingo-oophorectomy and umbilical hernia repair and possible staging procedure with lymph nodes.¿ ­ wound classification: not provided ­ findings: ¿the findings revealed an eight-week size uterus with a posterior fibroid, normal ovaries and tubes bilaterally.Frozen pathology revealed endometrial carcinoma at least to the middle third of the uterus, thus lymph node dissection was required.¿ ­ procedure: ¿anesthesia was induced and found to be adequate.The patient was prepped and draped in a normal fashion.A vertical incision was made and carried down 1 cm below the umbilicus.The fascia was incised with bovie superiorly and inferiorly.The peritoneal cavity was entered bluntly without difficulty.The peritoneal incision was extended superiorly and inferiorly with good visualization of the bladder.Using the bookwalter retractor the bowel was packed away with moist laparotomy sponges, peritoneal washings were obtained, the uterus was grasped with two large pean clamps and the round ligaments on both sites were suture ligated and transected.The retroperitoneal space was entered, and the infundibulopelvic ligaments on both sides were clamped with heaney clamps times two, transected and suture ligated.The bladder flap was created anteriorly with sharp dissection using metzenbaum scissors and the bladder was dissected off the lower uterine segment.The uterine arteries on both sides were skeletonized and clamped with curved heaney clamps, transected and suture ligated.Excellent hemostasis was noted.The remainder of the cardinal ligaments were clamped with straight heaney clamps down to the cervix, transected and suture ligated.The ectocervix was clamped with curved heaney clamps.The uterus and cervix were amputated above the clamps and handed over to pathology.The vaginal cuff angles were transfixed to the ipsilateral uterosacral ligaments and the remainder of the vaginal cuff was closed with a series of figure-of-eight sutures.At this point general surgery, dr.Navarro came in for the repair of the umbilical hernia.Two figure-of-eight sutures were made with prolene to repair the fascial defect on the umbilicus, however these stitches were removed after confirmation of the pathology report showed middle third invasion and nodes needed to be done.In order to proceed with lymph node dissection the vertical incision was extended approximately 3-inches above the umbilicus, thus the stitches of the umbilical hernia were removed.At this point (b)(6), m.D.Assisted with the surgery to proceed with lymph node dissection.The retroperitoneum was entered on the right and left sides with careful identification of the ureter.The common iliac, external iliac, and internal iliac vessels were carefully identified.There were lymph node dissections that took place in the common iliac area, the external iliac, as well as the obturator area.These dissections were carefully performed using clips for hemostasis.The borders that were used for the obturator lymph nodes included the superior vesicular artery, the obturator nerve inferiorly and the circumflex vein.Again these lymph nodes were carefully dissected from the right and left common iliac, external iliac and obturator.Please see dictation from (b)(6) m.D.For further details.After the node dissection was performed excellent hemostasis was noted after packing the spaces with ray-tec.The pelvis cavity had been copiously irrigated previous to the node dissection.All instruments were removed from the abdomen.At this point lawrence b.Kong, m.D.From general surgery was called in to complete the umbilical hernia repair.He used prolene sutures and did an undermining of the umbilical fascia and repaired the umbilical hernia using prolene sutures in a figure-of-eight fashion.The remainder of the incisional fascia was closed with 2-0 loop maxon suture as well as a series of interrupted sutures.The skin was closed with staples.The patient tolerated the procedure well.Sponge, lap, needle and instrument counts were correct times two.¿ ¿disposition: the patient was stable to the recovery room.¿ (b)(6) 2008: (b)(6), md.Operative report.Procedure: [ni.] preoperative diagnosis: [ni].Postoperative diagnosis: [ni].­ indications: ¿please see (b)(6), m.D.Operative note for the full procedure.The patient is a (b)(6) female was undergoing an abdominal hysterectomy for grade 1 adenocarcinoma of the endometrium with negative ecc, chest x-ray, and a normal ca-125.The frozen section on the uterine specimen showed grade 1 middle third invasion, and consequently a decision was made to proceed with a lymph node dissection.The lymph node dissection was somewhat complicated by marked intraabdominal adiposity.¿ ­ wound classification: not provided ­ procedure: ¿the abdominal incision was extended to approximately 4 cm above the umbilicus, extended to the left of the umbilicus.A bookwalter retractor was used.The lateral attachments of the sigmoid colon to the sidewall were separated using cautery and of the cecum on the right.In addition, on the right, there were extensive omental adhesions to the right lateral sidewall, extending down to the upper portion of the pelvis.These were all lysed with the lateral cecal attachments to be able to pack the bowel.The bowel was packed out of the pelvis using the bookwalter retractor.The lymph node dissection was done starting on the left and dissecting out the external iliac, internal iliac and obturator lymph nodes.Using the circumflex vein as the inferior margin, the superior vesicular artery of the medial margin and the obturator node as the inferior margin, the ureter was dissected free so that it was visible throughout the procedure.Common iliac nodes were also dissected.The genitofemoral nerve was identified and preserved.Hemoclips and cautery were used throughout the procedure for hemostasis.The same procedure was repeated on the right.On both sides, there was some abnormality of the vasculature with an anomalous large vein passing over the external iliac artery on the left approximately 1 cm proximal to the circumflex vein.The superior vesicular artery bilaterally branched more proximal than normal and came off at a right angle, and there were also veins in the obturator space.The genitofemoral nerve bilaterally was very close to the artery, and on the right side the common iliac node dissection extended directly into the node bundle, and at least a portion of it was excised.All spaces were rechecked for adequate hemostasis, and adequate hemostasis was observed.Specimens included the left common external and obturator.The internal iliac nodes were included with the obturator on the right.There was external, internal, obturator and common specimens.¿ (b)(6) 2008: (b)(6), md.Operative report.Assistant: (b)(6), md.Procedure: repair of wound dehiscence.Preoperative diagnosis: wound dehiscence.Postoperative diagnosis: wound dehiscence.Anesthesia: general.Estimated blood loss: 50 ml.Specimens: none.­ indications: ¿the patient is a (b)(6), g [gravida] 5 p [para] 3, with endometrial cancer.She was postoperative day #1 status post exploratory laparotomy, salpingo-oophorectomies staging procedure and umbilical hernia repair.She complained of an increased drainage of her incision and sensation of popping in the lower incision after coughing.Examination was significant for a 4-cm defect in the lower incision with extrusion of omentum.She was thus taken to the operating room for repair of wound dehiscence.Risks and benefits discussed.¿ ­ wound classification: not provided ­ procedure: ¿the patient was taken to the operating room where adequate anesthesia was ascertained.She was then prepared and draped in normal sterile fashion and placed in supine position.The incision was then opened with removal of the external staples.Examination was significant for a 4-cm defect in the lower incision at the level of the fascia with filmy fascial tissue.The existing 0 maxon suture was then removed.Consultation obtained from general surgery, dr.(b)(6), who recommended replacement of the 0 maxon sutures and placement of sternal retention sutures.Using 00 monosof, 5 external retention sutures were placed equidistant along the line of the abdominal incision through the skin, subcutaneous tissues, and fascia but just above the peritoneal layer.Attention was then placed at the level of the fascia where the fascia was repaired in a running manner using 0 maxon.A few interrupted sutures of 0 polysorb were placed at approximately every third suture.Once the fascia was properly secured the retention sutures were then tied and the skin was closed with staples.¿ ¿specimens: none.Estimated blood loss: 50 ml.Intravenous fluid: 2 l lactated ringer, 1 l hespan.At the end of the procedure all lap and instrument counts were correct x2.The patient tolerated the procedure well.She was transferred to recovery in stable condition.¿ (b)(6) 2008: fmc.(b)(6), md.Discharge summary.Hospital course: ¿the patient is a (b)(6) postmenopausal female with a history of vaginal bleeding who was diagnosed endometrial cancer from a dilatation and curettage in march of 2008.The patient was admitted on (b)(6) 2008 to undergo a total abdominal hysterectomy [tah] and bilateral salpingo-oophorectomy [bso], hernia repair, and exploratory laparotomy and possible staging for lymph node dissection.On (b)(6) 2008, the patient underwent an uncomplicated total abdominal hysterectomy and bilateral salpingo-oophorectomy, umbilical hernia repair, as well as lymph node dissection.The patient had an estimated blood loss during that surgery of 200 ml.On postoperative day number one the patient¿s vital signs were stable.Her pain was controlled with a dilaudid pca pump.Her postoperative hemoglobin was 11.8.Towards the late evening time, the patient was noted to have a significant amount of drainage in the lower half of her incision.The incision was probed with a q-tip and the staples were removed to allow drainage.At that time the fascia was noted to be intact.Approximately 2200 the ob [obstetrics]/gyn [gynecology] physician on-call was called to evaluate the patient as she continued to have increased leakage, and after getting up and going to the restroom and coughing, the patient was noted to have a significant amount of drainage with protruding omentum from her incision.This was also noted on physical examination, thus the patient was taken back to the operating room on (b)(6) 2008 for wound dehiscence and an exploratory laparotomy was performed.The sutures were noted to have ruptured the lower half of the incision.The general surgery service was called into the operation and retention sutures were placed after initial closure of the vertical incision.The patient had difficulty with extubation during second surgery, thus the internal medication service was called for a consultation.The patient remained intubated after surgery for approximately two to six hours.She was monitored down in the post anesthesia care unit [pacu] as there were no intensive care unit [icu] beds.Internal medicine was consulted, and it was actually thought to be secondary to persistent respiratory irritation and possibly a bronchitis type of picture.The patient was given breathing treatments and increased oxygen content.A chest x-ray was performed that showed a questionable left lower quadrant infiltrate.On postoperative day [pod] number two again the patient was extubated.Her pain was controlled.Her retention sutures were intact, her vital signs were stable, and she was afebrile.The patient at this time continued to be on a pca [patient controlled analgesia] pump.On postoperative day number three the patient began to tolerate clear liquids.She was passing gas.Her pain was controlled and her ambulation at this time was minimal.The patient also had a nasogastric tube placed which was clamped as the patient was beginning to tolerate clear liquids.On postoperative day number four the patient's vital signs were stable and she was afebrile.Her incision was healing well.The retention sutures were intact.Her potassium levels were a little low and this was replaced with iv [intravenous] potassium as well as p.O.[by mouth] potassium.The patient had her nasogastric [ng] tube removed.She was ambulating and feeling much better.On (b)(6) 2008, postoperative day number five, there were no changes.The patient was advanced in her diet slowly.She was ambulating.Her pain was controlled.On (b)(6) 2008, the patient was discharged home with her retention sutures and staples intact.She was given a follow-up appointment to come back in a week and a half for staple removal only, and in four to six weeks with dr.(b)(6) for her retention suture removal.Condition on discharge: stable.Discharge instructions: the patient is to return to the emergency room for severe abdominal pain, heavy bleeding, nausea or vomiting [n/v], or temperatures greater than 101 degrees fahrenheit.¿ (b)(6) 2008: fmc.(b)(6), md.Ct report.Procedure: ct abdomen and pelvis [ctap] without [w/o] contrast.Impression: ¿stranding noted in the anterior aspect of the low abdomen/pelvis, as well as anterior abdominal wall in the periumbilical region, which may represent postoperative change.There is a 1.5 cm fluid density in the right paraumbilical region, which may represent fluid collection or postoperative change.Because of the lack of intravenous contrast administration, superimposed infection may not be excluded in the anterior abdominal wall in the right paraumbilical region.Sigmoid colon diverticulosis without significant diverticulitis.There is no intraabdominal fluid collection.¿ (b)(6) 2008: (b)(6).Director: (b)(6), md.Blood culture report.¿final result: no growth at 5 days.¿ (b)(6) 2008: kp.(b)(6) md.Office note.Chief complaint [cc]: vaginal lump.¿pt had tahbso [total abdominal hysterectomy bilateral salpingo-oopherectomy] node dissection 4/08 follwed [sic] by reop [reoperating] days later for wound dehis [dehiscence].C/o [complains of] large bulge in lower left part of abd [abdomen], no [sic] very painful.¿ physical exam: abdominal: ¿hernia confirmed positive in the ventral area.¿ assessment: ¿incisional hernia.¿ orders placed: ctap.(b)(6) 2008 [date resulted]: kp.(b)(6), md.Ct report.Procedure: ctap w/o contrast.Indication: ¿a (b)(6) status post hysterectomy for uterine cancer in (b)(6)2008.Has postoperative wound with a large bulge in lower left abdomen, likely hernia.¿ impression: ¿1.Sigmoid diverticula without definite evidence for diverticulitis.2.Soft tissue inflammatory changes seen in the periumbilical region have diminished.The fluid collection seen on prior study has resolved.Again seen is laxity of the lower rectus abdominis muscle and sheath with moderate amount of fat seen between the sheath and the pubic symphysis.No bowel is identified within this region.¿ (b)(6) 2008: (b)(6), md.Office note.Physical exam: abdominal: ¿she exhibits distension and mass.Soft.No tenderness.She has no rebound and no guarding.4x5cm mass in lower left inguinal area.Soft, non-tender.¿ assessment: ¿inguinal mass.Likely hernia.¿ plan: ¿referral to general surgery for further evaluation.¿ (b)(6) 2008: (b)(6), md.Office note.Cc: ¿consultation ((b)(6) with history of uterine cancer s/p [status post] hysterectomy/ventral hernia repair with subsequent wound dehiscence retention sutures by dr.Ong) back in 4/08 now presents with inguinal mass that may be a hernia.Please see ct scan done 10/08).¿ history: ¿she developed an orange size bulge in the left groin which does not cause any symptoms.¿ ¿no pain other than at her previous midline incisions.¿ physical exam: abdominal: ¿bowel sounds are normal.She exhibits no distension and no mass.Soft.No tenderness.She has no rebound and no guarding.No hernia.Hernia confirmed negative in the umbilical area, confirmed negative in the ventral area, confirmed negative in the right inguinal area and confirmed negative in the left inguinal area.¿ a/p [assessment/plan]: ¿pt has a laxity but no true hernia.I would not recommend anything but observation at this time.F?u [sic; follow up] prn [as needed ].¿ (b)(6) 2009: (b)(6), md.Office note.History: ¿pt here for f/u of hernia.Noticed a new bulge in left abdomen approximately 2 months ago.Causeing [sic] aching pain.Reduces when pushed on.No n/v or obstructive symptoms.Pain is 4/10.¿ physical exam: abdominal: ¿bowel sounds are normal.She exhibits no distension and no mass.Soft.No tenderness.She has no rebound and no guarding.¿ ¿pt with a ventral hernia.Discussed the risks of laparoscopic ventral hernia repair with mesh including bleeding requiring reoperation or transfusion.Infection requiring antibiotics, drainage of abscess, or mesh removal.I discussed the risk of bowel or other organ injury and that if the injury was recognized i would fix the bowel injury, end the operation, and admit for observation and they would need a second operation at a later date to fix the hernia.I discussed the risk of a missed bowel injury requiring reoperation and mesh removal with subsequent hernia recurrence.I discussed the chance they may get a recurrence, and this may require more surgery.I discussed the postoperative course and that there may be a significant amount of pain with the procedure.Finally i discussed the risk of anesthesia including mi [myocardial infarction], cva [cerebrovascular accident], pe [pulmonary embolus], aspiration etc.The pt wishes to proceed with surgery.¿ (b)(6) 2009: (b)(6), md.Office note.¿pt is also very tearful today because she keeps cancelling her surgery for her ventral hernia repair out of fear from the pain.She states the surgeon told her that this surgery is very painful.She has cancelled twice now.I spent a while discussing surgery with patient.Her previous surgery for uterine cancer was quite painful due to wound dehiscence and having retention sutures.I explained to patient that her hernia repair is lsc [unknown abbreviation] and would not likely be as painful as the gyn surgery.Pt states that she feels much better about it now and is requesting that i send an email to her surgeon requesting a new surgery date in november.¿ implant preoperative complaints: (b)(6) 2009: (b)(6), pa.Office note.Cc: ¿incisional ventral hernia(s)¿ hpi [history of present illness]: ¿(b)(6) female who had a total abdominal hysterectomy and ventral hernia repair approximately 1.5 years ago for uterine cervical cancer.Post operatively, it sounds like she had a wound dehiscence and had to be taken back to the or.The patient remembers having retention sutures in place for 2 months.She also spent some time in the icu.Since then the patient has had recurrent hernias.They are bothersome and have been getting larger.The patient denies n/v.She does have recurrent diarrhea (ibd [irritable bowel disease]).The patient had a surgical consultation with dr tessier.She has agreed to proceed with a laparoscopic vs open ventral hernia repair with mesh.¿ abdominal: ¿obese.Midline scar with possible small hernia above umbilicus, a second hernia below umbilicus left of midline, and another hernia in llq [left lower quadrant].¿ plan: ¿the patient has been seen and examined by dr (b)(6).She is scheduled for a laparoscopic ventral (incisional) hernia repair with mesh, possible exploratory laparotomy on (b)(6) 2009 in fontana.The patient would also like to be admitted overnight after surgery.All risks versus benefits have been discussed with the patient by dr.(b)(6).These risks include, but are not limited to the possibility of bleeding, infection, injury to underlying organs, use of artificial mesh which will be permanently retained, possible recurrence of the hernia and the risks of anesthesia.The patient understands these risks versus benefits and wishes to proceed with the surgery.We will obtain preop labs and an ecg [electrocardiogram].She will also have an anesthesia consultation per the patient's request.¿ implant procedure: laparoscopic ventral hernia repair.[implant: gore® dualmesh® plus biomaterial, 1dlmcp08/ni, 24cm x 36cm x 1mm thick, oval.] see attachment for h10 continuation.
 
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Brand Name
GORE® DUALMESH® PLUS BIOMATERIAL
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key14431641
MDR Text Key291973075
Report Number3003910212-2022-01354
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00733132601158
UDI-Public00733132601158
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K063435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 02/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/30/2011
Device Model Number1DLMCP08
Device Catalogue Number1DLMCP08
Was Device Available for Evaluation? No
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/20/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
Patient Weight107 KG
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