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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES GORE DUALMESH PLUS BIOMATERIAL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 1DLMCP06
Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Seroma (2069); Infection, Pyrogenic (2246); No Code Available (3191)
Event Date 06/21/2011
Event Type  Injury  
Manufacturer Narrative
Added medical history. (b)(4). (b)(6). It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and 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. ¿.
 
Event Description
It was reported to gore that the patient underwent laparoscopic incisional and umbilical hernia repair on (b)(6) 2010 whereby a gore dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2011, an additional procedure occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: debridement of chronically infected abdominal wound, infections, additional surgeries, mesh removal, and mesh failure. Additional event specific information was not provided.
 
Manufacturer Narrative
Added medical history. Conclusion code remains unchanged. Added medical record information. Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: (b)(6) 2011: (b)(6) medical center. (b)(6), md. Ct guided needle placement. History: infected postop seroma. Findings: there is an oval collection of low attenuation measuring up to 11. 1 x 5. 5 cm. Radiopaque rim of the collection is seen and may represent some type of surgical radiopaque mesh used to repair and anterior abdominal wall hernia. The fluid was grossly purulent. A single incompletely healed skin site is demonstrated and may have represented the site of a draining sinus tract. Impression: ct guided percutaneous drainage of an infected seroma was performed. Fluid sample pending. (b)(6) 2011: [missing records: a culture report detailing analysis of the specimens collected during the (b)(6) 2011 procedure was not provided. ] (b)(6) 2011: (b)(6) medical center. (b)(6), md. Radiology-ct abdomen/pelvis without contrast. Indication: abscess. Findings: there has been a ventral hernia repair with surgical mesh. A new percutaneous drainage catheter courses through the mesh and has markedly decreased the fluid collection underlying the mesh. There is no identifiable residual with unopacified small bowel loops deep to the mesh. Just superior to the surgical mesh, ventral hernia remains containing fat and bowel loops. Surgical suture in the right lower quadrant abdomen at the cecum. Impression: evacuation of the fluid collection just deep to the surgical mesh without residual fluid collection. Left hydrosalpinx. (b)(6) 2011: (b)(6) medical center. (b)(6), md. Interventional radiology. History: abscess. Procedure: abscessogram. Findings: fluoroscopic evaluation demonstrates an amorphous collection filling what appears to be at least a moderate size cavity. No evidence of fistula. The output has been approximately 20 cc per day. The catheter was left in place. Impression: abscessogram demonstrates a moderate-sized cavity. The patient still reports significant output. (b)(6) 2011: (b)(6) medical center. (b)(6), md. Interventional radiology. Injection of abdominal wall abscess catheter and subsequent removal. Indication: patient is approximately 3 weeks status post placement of a drainage catheter just below the abdominal wall mash [sic]. Patient states that she has been recently a febrile [sic, afebrile]. The drainage from the catheter has been approximately 15 cc per day of relatively mild serosanguinous fluid. Impression: removal of abdominal wall fluid collection drainage catheter. (b)(6) 2011: (b)(6) medical center. (b)(6), md. Radiology- ct abdomen with contrast. History: peritoneal abscess. Findings: on the previous study, the patient had a pigtail catheter placed into a seroma in the anterior abdominal wall. This is seen related to surgical mesh from a previous hernia repair. The fluid collection has reaccumulated following removal of the pigtail catheter. It now measures 4. 4 x 9. 8 cm in size on image 64. It has hounsfield numbers of 27 which is a little more than would be expected for simple fluid. The umbilical hernia remains containing fat and there are some bowel loops which may be related to the hernia as well. Overall, the size of the hernia has not increased since the previous study. There is no adenopathy in the abdomen. No abnormal fluid collections are seen other than the presumed seroma at the hernia site, but a residual ventral hernia is seen. Impression: reaccumulation of fluid at the site of the previous percutaneous drainage. This is probably a recurrent seroma measuring 9. 8 x 4x4 cm in size. It is related to the surgical mesh placed at hernia repair. There is still residual hernia as discussed above. (b)(6) 2011: (b)(6) medical center. (b)(6), md. Ct guided needle placement. History: recurrent postop seroma. Procedure: ct-guided drainage. Operator: (b)(6) np. Supervisor: harp, md. Findings: limited unenhanced ct examination demonstrates a postop seroma with mesh. Successful catheter placement in good location. (b)(6) 2011: [missing records: a culture report detailing analysis of the specimens collected during the (b)(6) 2011 procedure was not provided. ] (b)(6) 2011: (b)(6) medical center. (b)(6), md. Radiology-ct abdomen/pelvis with contrast. Indication: status post hernia repair with jackson-pratt drain in place. There is purulent fluid about the drain. Ct abdomen with contrast: there is now a surgical drain in place at the midline ventral wall. A fluid collection with surrounding rim calcification at this site is now collapsed. Herniated mesenteric fat through the ventral wall defect appears stable. No new suspicious enhancing mass of fluid collection otherwise is seen. The small bowel and colon are not remarkable. There is no evidence of any free air in the abdomen. Impression: post surgery change at the ventral wall periumbilical region with a surgical drain in place. The fluid collection seen before with surrounding rim calcifications is collapsed and there are otherwise is no new acute appearing abnormality seen in the abdomen and pelvis, as above. (b)(6) 2012: (b)(6) medical park. (b)(6), md. Office notes. Low grade fever, nausea, abdominal pain, etiology uncertain with recent tick bite. (b)(6) 2012: (b)(6) medical center. (b)(6), md. Ct guided needle placement. History: abdominal abscess, status post abdominal wall hernia repair. Procedure: ct scan guided percutaneous drainage of the anterior abdominal fluid collection. Grossly purulent fluid was removed to a volume of approximately 100 ml. Samples submitted to laboratory for microbiology. (b)(6) 2012: [missing records: a culture report detailing analysis of the specimens collected during the (b)(6) 2012 procedure was not provided. ] (b)(6) 2012: (b)(6) medical center. (b)(6), md. Interventional radiology. History: abdominal abscess. Impression: successful abscess catheter check which still demonstrates residual abscess remaining and thus the catheters left in place. (b)(6) 2012: (b)(6) medical center. (b)(6), md. Interventional radiology. Indication: treatment of infection the adjacent to anterior abdominal wall mash [sic]. Impression: slight reduction in overall size of fluid collection. Catheter changed. (b)(6) 2012: (b)(6) medical center. (b)(6), md. Interventional radiology. History: abdominal abscess. Percutaneous drainage. Impression: improvement with a small amount of residual abscess. (b)(6) 2012: (b)(6) medical center. (b)(6), md. Interventional radiology. Impression: essentially, there is marked reduction in the patient¿s collection. However a potential space still exists which can be filled with contrast. The tube was left in place as discussed with dr. (b)(6). (b)(6) 2012: (b)(6) medical center. (b)(6), md. Radiology-us-abdominal. Indication: abdominal pain. Impression: at site of pain, there is a complex collection of uncertain etiology by ultrasound. Ct could be performed. (b)(6) 2013: (b)(6) medical center. (b)(6), md. Radiology-ct abdomen/pelvis with contrast. Indication: nausea vomiting fever chills epigastric pain. Evaluate for abdominal wall abscess. Abdomen: patient apparently has had an anterior abdominal wall hernia repair. There is a thick walled gas and fluid collection deep to the hernia repair in the anterior abdomen measuring about 7. 2 x 2. 6 cm. This is in an area of prior drainage. There is good opacification of adjacent bowel loops and i do not believe this represents of bowel. There does appear to be a small residual hernia containing adipose tissue. Pelvis: there is a 4. 7 cm left adnexal cystic structure. Along its inferior extent it appears to be somewhat tubular extending to the right above the bladder and the question is raised whether this could be a combination of ovarian cyst and hydrosalpinx. No free fluid. Impression: deep to an anterior abdominal wall hernia repair there is a thick walled gas and to a lesser extent fluid collection measuring 7. 2 x 2. 6 cm that does not appear to be bowel and would be concerning for recurrent/residual abscess. There is a small residual anterior abdominal wall hernia containing adipose tissue. Question left-sided hydrosalpinx/ovarian cyst. Consider a follow up. (b)(6) 2013: (b)(6) medical center. (b)(6), md. Interventional radiology. History: recurrent midline abdominal abscess status post mesh repair of an abdominal wall hernia. Patient presents for repeat percutaneous drainage. Impression: difficult drain placement due to the extensive scar tissue and/or thickening from the mesh. However, an 8-french tube was placed into the collection and only a scant amount of drainage fluid could be aspirated and sent for microbiology. (b)(6) 2013: (b)(6) medical center. (b)(6), md. Interventional radiology. Catheter check and limited abdominal ultrasound. Vacation: anterior abdominal wall abscess treated with catheter drainage approximately 19 days ago. Impression: fistula to small bowel. [(b)(4)] (b)(6) 2013: (b)(6) medical center. (b)(6), md. Radiology-mri pelvis with and without contrast. Clinical information: history of intracutaneous fistula status post drainage. Impression: complex enhancing soft tissue along the anterior abdominal wall involving the right greater than left rectus sheath is likely in keeping with history of enterocutaneous fistula. (b)(6) 2013: (b)(6) medical center. (b)(6), md. Radiology-ct abdomen/pelvis with contrast. Indication: enterocutaneous fistula status post drainage. Impression: similar appearance of left hydrosalpinx. Resolution fluid collection anterior lower abdomen with only residual present scar tissue remaining. No drainable collection on today¿s study. (b)(6) 2014: (b)(6) medical center. (b)(6), md. Radiology-ct abdomen/pelvis with contrast. History: pelvic pain, history cesarean section, tubal ligation, appendectomy. Impression: findings could represent acute mild uncomplicated sigmoid diverticulitis in the appropriate clinical setting. Interval slight increase in size of probable left hydrosalpinx. [(b)(4)] (b)(6) 2015: (b)(6) medical center. (b)(6), md. Radiology-ct abdomen/pelvis with contrast. Indication: abdominal pain. Impression: chronic left hydrosalpinx, hepatic steatosis. (b)(6) 2017: medical group of (b)(6). (b)(6), md. Office visit. Presents on referral secondary to a history of enterocutaneous fistula. This was noticed on mri in 2013. At that time she had a [sic] abdominal wound infection. However this is healed. She does state periodic 5 out of 10 abdominal pain occasional nausea no vomiting occasional constipation no diarrhea no melena no hematochezia no dysuria no hematuria no fevers or sweats. Positive occasional chills. She denies any open wounds on her abdomen. Assessment/plan: fistula of intestine. This appears to have healed completely. A potential relationship, if any, between the alleged injuries or complications and the gore device is unclear from the provided information at this time. It should be noted that the gore dualmesh® plus biomaterial instructions for use includes warnings and 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. ¿.
 
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Brand NameGORE DUALMESH PLUS BIOMATERIAL
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MPD APC B/P
p.o. box 1408
elkton MD 21922 1408
Manufacturer Contact
kathy titus
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key8217481
MDR Text Key132080554
Report Number3003910212-2019-00003
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2011
Device Model Number1DLMCP06
Device Catalogue Number1DLMCP06
Device Lot Number06306940
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/03/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/04/2019 Patient Sequence Number: 1
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