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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® DUALMESH® BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMC03
Device Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Unspecified Infection (1930)
Event Date 05/01/2009
Event Type  Injury  
Manufacturer Narrative
Added medical record information. Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: implant procedure: laparoscopy with repair of ventral incisional hernia at the umbilicus with gore-tex dualmesh 10 x 15 x 1. Implant: gore® dualmesh® biomaterial [1dlmc03/(b)(4), 10 cm x 15 cm]. Implant date: on (b)(6) 2009 (hospitalization [ni]). On (b)(6) 2009: at (b)(6). (b)(6), md. Operative report. Preoperative diagnosis: recurrent ventral incisional hernia. Postoperative diagnosis: small new ventral hernia inferior to previously placed right subcoastal mesh in umbilicus, and mild eventration of mesh right upper quadrant. First assistant: dr. (b)(6). Anesthesia: general endotracheal. Indications for procedure: this is a very pleasant (b)(6) year-old woman who in (b)(6) of last year underwent laparoscopic repair of a right subcoastal ventral incisional hernia with proceed mesh. She did a lot of activity in (b)(6) 2008, and developed a bulge in the right subcoastal position. Ct abdomen and pelvis demonstrated what appeared to be a recurrent hernia in the superolateral portion of the mesh, as well as at the level of the umbilicus. She is desirous of repair. Intraoperative findings: mild eventration of the proceed mesh in the right upper quadrant without herniation of tissue through any defect in the right upper quadrant. A small, about 4-centimeter diameter at the umbilicus just inferior to the previously placed mesh repaired by the gore-tex dualmesh. Blood loss was approximately 25 cc. Description of operative procedure in detail: ¿the patient was identified as (b)(6), taken to the operating room and placed in the supine position. Sequential compression hose were placed on the bilateral lower extremities. Following induction of adequate general endotracheal anesthesia, the patient's abdomen was prepped and draped in the usual sterile fashion with betadine and an loban drape, 0. 25% marcaine with epinephrine was placed at each incision site. The previous left subcostal incision was opened with the scalpel, and dissection continued posteriorly. The fascia was incised with a scalpel and underlying muscle spread with a hemostat and the posterior fascia and peritoneum opened. The surgeon's finger confirmed intraperitoneal location and the applied medical balloon hasson trocar was placed in the peritoneal cavity, its balloon inflated until insufflation to a level of 15 mmhg ensued. Two left-sided 5-millimeter trocars were placed in the peritoneal cavity under direct laparoscopic view after incision of the skin with scalpel. Omental adhesions were identified throughout the entire midline of the abdomen extending in the right lower quadrant. These were able to be taken down nicely using a blunt grasper, peeling the omentum off the peritoneum. Reduction of a hernia at the inferior aspect of the previously placed mesh was performed just at the level of the patient's umbilicus. The omentum was adherent to the subcostal mesh and the hepatic flexure of the colon was adherent as well, which was easily and safely removed from the previously placed mesh. The area of the patient's bulge was broadly covered by the mesh and there was some mild eventration of the mesh at this location but certainly no full-thickness hernia defect was identified. The patient's edge of her liver was adherent to the superior aspect of the mesh and this was left alone. Photographs were taken. Plans were made for repair of the periumbilical incisional hernia and a 10 x 15 piece of gore-tex dualmesh was selected, marked on the smooth side 0 cvs sutures placed at each corner and the mesh was placed into the peritoneal cavity and unrolled. Sutures in each corner of the mesh were then brought out through separate stab incisions using the gore suture passer and the sutures tied down in this location after decreasing the intra-abdominal pressure to 15. The protack was then used to place tacks every one to two centimeters along the periphery of the mesh. Photographs were taken of the completed repair. There was a small amount of bleeding from an inferior epigastric vessel at a suture fixation site which was controlled with a single 2-0 vicryl suture, which was placed using the gore suture passer. This nicely stopped the bleeding. The remaining local anesthetic was placed in the peritoneal cavity after suctioning a small amount of blood from the peritoneum. The trocars were removed under direct visualization. There was no evidence of bleeding from the trocar sites. The abdomen was desufflated through the subcostal port which was then removed. The fascial incisions were closed with running 2-0 vicryl in the fascia and peritoneum and a 0 vicryl in the anterior fascia. The skin incisions were approximated with 4-0 vicryl subcuticular sutures. Dressings were applied with mastisol and 1/2-inch brown steri-strips, a sterile towel and abdominal binder. The patient tolerated the procedure well without apparent complication. ¿ counts: sponge, needle and instrument counts were correct at the end of the case. On (b)(6) 2009: at (b)(6). Implant sticker. Gore dualmesh® biomaterial. Ref catalogue number: 1dlmc03. Lot batch code: (b)(4). W. L. Gore & associates. [handwritten on implant log]: 10 cm x 15 cm x 1. 0 mm. The records confirm a gore® dualmesh® biomaterial (1dlmc03/(b)(4)) was implanted during the procedure. Implant procedure: laparoscopic repair of right subcoastal ventral incisional hernia with goretex dual mesh, 10 x 15 x 1. Implant: gore® dualmesh® biomaterial [1dlmc03/(b)(4), 10 x 15 cm]. Implant date: (b)(6) 2010 (hospitalization [ni]). On (b)(6) 2010: at (b)(6). (b)(6), md. Operative report. Preoperative diagnosis: recurrent right subcoastal ventral incisional hernia. Postoperative diagnosis: recurrent right subcoastal ventral incisional hernia. Anesthesia: general endotracheal. Indications: a very pleasant (b)(6) year-old caucasian woman who had undergone previous repair of a right subcostal ventral incisional hernia with proceed mesh about four or five years ago and then subsequent laparoscopic repair of an umbilical incisional hernia with goretex dual mesh in the past as well. About two weeks ago she had a gi bug, was vomiting and got right subcostal pain. When she twists or turns it can grab, pull, lock and create pain. Physical examination demonstrates, in the center of her right subcostal incision, a bulge that is tender with some minor discomfort on reduction. Plans are made for laparoscopic evaluation and repair. Intraoperative findings: excellent position of the subcostal proceed mesh. Maybe slight invagination of the mesh and a weakness. This area was broadly covered internally with a 10 x 15 x 1 piece of goretex dual mesh. Blood loss was less than 50 cc. Description of procedure in detail: ¿the patient was identified as (b)(6), taken to the operating room and placed in the supine position. Sequential compression hose were placed on bilateral lower extremities. Following the induction of adequate general endotracheal anesthesia, the patient's abdomen was prepped and draped in the usual sterile fashion with betadine and a loban drape. 0. 25% marcaine with epinephrine was placed at each incision site. A previous left subcostal 3 cm incision was infiltrated with local anesthetic, incision carried out with a scalpel and dissection taken posteriorly using a hemostat spread the subcutaneous tissue, the anterior fascia, the muscle and the posterior fascia allowing entry into the peritoneal cavity. The applied medical balloon with hasson trocar was placed into the peritoneal cavity, its balloon inflated with c02 insufflation until the level of 15 mmhg ensued. A left midabdominal 5-millimeter trocar was placed in the preperitoneal cavity under direct laparoscopic view after incision of the skin with a scalpel. Using a grasper and scissors where indicated, no electrocautery, no power sources, omental adhesions were taken down from the previously placed mesh as well as adhesion of the right lobe of the liver to the mesh. This created a small amount of oozing but no significant bleeding points and the oozing stopped on its own. The area was completely cleared and a thorough evaluation showed possible slight indentation in the medial portion of the mesh with invagination of the mesh into this area. Externally this correlated with the center of the subcostal incision where clinically she the pain and the bulge. A 10 x 15 x 1 piece of goretex dual mesh was selected, marked on the smooth side and four stay sutures placed and gore suture was rolled, placed in the peritoneal cavity with the assistance a second 5-millimeter trocar and a blunt grasper unrolled and the sutures brought out in four separate positions using the gore suture passer. Prior to tying down the most inferior sutures, two additional sutures were passed through separate stab incisions using a gore suture passer to adequately fasten the mesh superiorly below the costal margin. The inferior two sutures were then tied down and the mesh was fastened to the posterior abdominal wall using the protac device. Tacks were one to two centimeters around the periphery of the mesh. Photographs were taken of completed repair and broadly covered the area of concern. A small amount of bloody drainage was suctioned out with a suction device. No active bleeding was noted after thorough evaluation of the intraabdominal cavity. There was no evidence of bowel involvement in any of the adhesions and therefore no bowel injury was suspected or identified. The remaining local anesthetic was placed in the subdiaphragmatic position. Trocars were removed under direct visualization. There was no evidence of bleeding from the trocar sites. The abdomen was desufflated through the subcostal portion which was then removed. The abdomen was actively desufflated through the subcostal incision. The posterior fascial incision was closed with running 2-0 vicryl. The anterior fascia was closed with running 0-vicryl. The skin incisions were approximated with a 4-0 monocryl subcuticular sutures. Dressings were applied with mastisol and half-inch brown steri-strips, a sterile towel and abdominal binder. The patient tolerated the procedure well without apparent complication. The sponge, needle and instrument counts were correct at the end of the case. ¿ on (b)(6) 2010: at (b)(6). Implant record. Procedure: laparoscopic repair recurrent incisional hernia. Implant site: right subcoastal area-abdomen. Catalog #: 1dlmc03. Lot #: (b)(4). Description: gore dualmesh 10 x 15 cm. Expiration date: 12-21-2014. Total qty used: 1. # implanted: 1. The records confirm at gore® dualmesh® biomaterial (1dlmc03/(b)(4)) was implanted during the procedure. Relevant medical information: on (b)(6) 2010: at (b)(6). (b)(6), md. History and physical. Possible mesh infection, pain and abnormal irritation since mesh placed in right upper quadrant. Recent ct showed possible seroma. Egd showed mild gastritis. Symptoms suggestive of possible mesh reaction. History of chronic obstructive pulmonary disease, tobacco abuse. Surgical history: ventral hernia repairs, hysterectomy. Social history: current smoker, 1 pack per day, 25 years. Disabled. Impression/plan: possible mesh infection, well remove mesh, repair primarily. Explant procedure: excisional debridement of fascia with removal of mesh, repair of ventral hernia. [type of mesh ni]. Explant date: (b)(6) 2010 (hospitalization (b)(6) 2010). On (b)(6) 2010: at (b)(6). (b)(6), md. Operative report. Preoperative diagnosis: right upper quadrant pain, probable mesh reaction. Postoperative diagnosis: mesh infection, recurrent ventral hernia. Anesthesia: general. Specimen: culture and mesh. Estimated blood loss: twenty-five milliliters. Operative indications: a (b)(6) year-old female who has had laparoscopic repair of recurrent ventral hernia in about (b)(6). She has had persisting symptoms in that area. She has a fluid collection around it on computerized axial tomography scan. She presented for removal of mesh from possible mesh reaction. Procedure findings: showed some brownish fluid, probably an old infected hematoma around the mesh. When repairing the hernia there was a minimal amount of muscle in the subcostal region. Apparently, her original cholecystectomy did not have 2 fingerbreadths below. I repaired the area primarily because of increased risk of recurrent infection. If she does develop a recurrent hernia, we will need to repair this in the future with a more formal mesh. Operative technique: ¿the patient was brought to the operating room and placed on the operating table in the supine position. There she underwent induction of general anesthesia. The abdomen was sterilely prepped and draped with duraprep even though she has an iodine allergy she states she does tolerate topical iodine. After confirming appropriate patient and procedure via time-out local anesthetic was infused. A skin incision was made. Dissection was carried down through down to the fascia. There was bulging in that area. There was fatty tissue there. This was dissected down until the mesh was identified. With dissection through the mesh there was a rush of brownish fluid, opened up the mesh underneath it and there was old digested hematoma with a capsule around it. This area was opened up. The mesh was excised including the protacks. There was a defect in the inferior aspect about 4 centimeters. After removing the mesh that area was irrigated. The defect was closed with 0 vicryl. Then the muscle layers were brought together with interrupted #1 prolene figure-of-eight sutures. The scarpa's was closed with 3-0 vicryl and the skin was closed with 4-0 monocryl. The wounds were dressed and the patient was awakened. An abdominal binder was placed on the patient. The patient was then returned to the post anesthesia care unit in good condition. All sponge counts, needle counts, and instrument counts were reported as correct. ¿ relevant medical information: on (b)(6) 2010: at (b)(6). (b)(6), md. Pathology. Accession: (b)(6). Final diagnosis: removal of infected mesh: densely fibrotic soft tissue with embedded synthetic mesh and associated foreign body histiocytic reaction and chronic inflammation. Specimen: foreign body mesh. Clinical information: preoperative diagnosis: infected mesh. Gross description: received fresh, labeled (b)(6), ¿foreign body mesh" are 3 pink gray membranous gray to tan brown rubbery fragments of tissue that have attached sutures and metal coils, 3. 5 x 2. 1 x 0. 3 cm to 10. 5 x 7. 7 x 0. 2 cm. Also contained are multiple nonviable red tan soft rubbery fragments of tissue, 5. 5 x 3. 5 x 1. 2 cm in aggregate. On (b)(6) 2010: at (b)(6). Microbiology. Culture tissue. Body site: abdomen. Final: no growth 48 hours. Gram stain: no wbc¿s seen. No organisms seen. On (b)(6) 2010: at (b)(6). Lab. Wbc 12. 2 h (3. 4-10. 1). On (b)(6) 2010: at (b)(6). (b)(6), md. Discharge summary. Discharge diagnosis: mesh reaction, possible mesh infection, right upper quadrant pain. Admitted after removal of mesh with possibly infected hematoma around it. Postoperatively, had some issues with pain and eventually weaned to by mouth pain pills and was discharge home in good condition on (b)(6) 2010. Discharge meds: prescription for percocet. Follow up 2 weeks. Call if any worsening symptoms. On (b)(6) 2010: at (b)(6). (b)(6), md. History and physical. Recurrent ventral hernia, confirmed recently had mesh removed, has been wearing binder, had recent coughing episode and hernia recurrent. Will need to repair with mesh. Impression/plan: recurrent ventral hernia. Hernia repair, high risk of recurrence because of proximity to ribs and little muscle to sew to. On (b)(6) 2010: at (b)(6). (b)(6), md. Operative report. Preoperative diagnosis: recurrent ventral hernia. Postoperative diagnosis: recurrent ventral hernia. Recurrent ventral hernia repair with mesh. Anesthesia: general. Estimated blood loss: 25 ml. Implants: ultrapro flat mesh. Operative indications: a (b)(6) year-old female who had recent mesh removal and was unable to replace with mesh at the time, has developed recurrence. Procedure findings confirmed the recurrence in the medial previous incision, i was able to reduce this and opened up to layer a larger piece of flat ultrapro mesh into the subfascial plane. This was affixed with 0-prolene. Operative technique: ¿the patient was brought to the operating room and placed on the operating room table in supine position. After establishing general anesthesia, the abdomen was sterilely prepped and draped with duraprep. After confirming appropriate patient and procedure via a time-out local anesthetic was infused. A skin incision was made over the previous incision. Dissection was carried down to the fascia. The defect was identified. This was reduced. I felt underneath the subfascial plane, some weakness laterally, so i opened this up in order to be able to place a larger mesh, left more of muscle flaps so that i could sew the mesh to it better than she had had originally. The mesh was affixed in the subfascial plane with 0-prolene in multiple locations around the defect. The defect was then closed with interrupted 0-prolene suture. The wound was irrigated. The deep tissue was closed with 3-0 vicryl. The skin was closed with 4-0 monocryl. The wounds were dressed. The patient was awakened and returned to the post anesthesia care unit in good condition. All sponge counts, needle counts and instrument counts were reported as correct. ¿ on (b)(6) 2010: at (b)(6) medical center. Implant sticker. [poor copy quality, difficult to read]. Ultrapro. Lot: [illegible]. Exp: jun 2015. Ethicon¿. On (b)(6) 2010: at (b)(6). (b)(6), md. Consultation. Admitted on (b)(6) 2010. Recurrent ventral hernia. Had prior ventral hernia repair. Recently had the mesh removed. She has been wearing a binder and had some coughing episode and the hernia recurred. Now status post recurrent ventral hernia repair with mesh postoperative day #2. Longstanding history of tobacco abuse, diagnosed with chronic obstructive pulmonary disease. On oxygen at this time. This is her 3rd hernia repair. Smoked ½ pack. Exam: abdomen: abdominal binder in place. Impression/plan: status post ventral hernia repair, postoperative day #2. Postoperative fever, etiology unknown with productive yellowish sputum. Rule out atypical pneumonia. Infectious disease following. Discussed strict smoking cessation. On (b)(6) 2010: at (b)(6). (b)(6), md. Discharge summary. Discharge diagnosis: recurrent ventral hernia. Hospital course: admitted after repair of recurrent ventral hernia; was having some fevers and found to have pneumonia. Discharge meds: doxycycline, levaquin, percocet. Follow up on (b)(6) 2010. Discharge instructions: call if she has any worsening symptoms, wear binder. On (b)(6) 2011: at (b)(6). (b)(6), md. History and physical. Recurrent ventral hernia. Had hernia repair with mesh in (b)(6) 2010. Now has small defect superior to area, has been trying to quit smoking to reduce coughing episodes. Impression/plan: recurrent ventral hernia. Repair recurrent ventral hernia. On (b)(6) 2011: at (b)(6). (b)(6), md. Operative report. Preoperative diagnosis: recurrent ventral hernia. Postoperative diagnosis: recurrent ventral hernia. Repair of recurrent ventral hernia with mesh. Assistant: (b)(6), crnfa. Anesthesia: general. Specimen: none. Implant: ultrapro flat mesh. Estimated blood loss: 5 ml. Operative indications: a (b)(6) year-old female who has had previous right upper quadrant hernias, had a recurrence. Procedure findings confirmed a defect. This was repaired by imbricating the muscle and laying a flat piece of mesh over it. Operative technique: ¿the patient was brought to the operating room, placed on the operating table in supine position after establishing general anesthesia. The abdomen was sterilely prepped and with duraprep. After confirming appropriate patient and procedure via time out local anesthetic was infused. A skin incision was made over the preoperatively marked area. Dissection was carried down to the fascia. The bulging area was identified, it was imbricated with running 0 prolene. A flat piece of mesh was affixed over the top of the that with 0 prolene. The layers above it were then closed with 3-0 vicryl. Skin was closed with 4-0 monocryl. Wounds were dressed. The patient was awakened to returned to the post anesthesia care in good condition. All sponge counts, needle counts, instrument counts reported as correct. ¿ on (b)(6) 2011: at (b)(6). Implant sticker. [poor copy quality, difficult to read]. Ultrapro mesh. Lot: [illegible]. Ethicon¿. On (b)(6) 2013: at (b)(6). (b)(6), md. Office notes. Present with other hernias right abdomen. Possible recurrent ventral hernia on right side of abdomen. Pain can increase to a 10 and radiate to back. Increasing in size, reducible. Weight (b)(6) lbs, bmi 25. 4. Exam: no abdominal tenderness. Impression/plan: recurrent ventral hernia. Repair recurrent ventral hernia.
 
Event Description
It was reported to gore that the patient underwent laparoscopic ventral hernia repair on (b)(6) 2009, and (b)(6) 2010, whereby a gore® dualmesh® biomaterial was implanted. It was reported the patient alleges the following injuries: recurrent right subcostal ventral incisional hernia, additional surgical procedure required, and omental adhesions. Additional event specific information was not provided.
 
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Brand NameGORE® DUALMESH® BIOMATERIAL
Type of DeviceMESH, 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
megan reigh
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11925599
MDR Text Key264120378
Report Number3003910212-2021-01228
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992189
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
Report Date 01/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/25/2014
Device Model Number1DLMC03
Device Catalogue Number1DLMC03
Was Device Available for Evaluation? No
Date Manufacturer Received01/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2009
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/02/2021 Patient Sequence Number: 1
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