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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 1DLMCP03
Device Problem Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Obstruction/Occlusion (2422)
Event Date 11/08/2019
Event Type  Injury  
Event Description
It was reported to gore that the patient underwent laparoscopic incisional hernia repair on (b)(6) 2015 whereby a gore® dualmesh® plus biomaterial was implanted. The complaint alleges that on (b)(6) 2019 and (b)(6) 2020, additional procedures occurred whereby the gore device was explanted. It was reported the patient alleges the following injuries: none reported. 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)]. Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: relevant medical information: none provided. Implant preoperative complaints: (b)(6) 2015: (b)(6) medical center. (b)(6) indication: ¿the patient is a (b)(6) male who had a previous appendectomy with incision at his umbilicus. He developed a hernia and this had been enlarging and is symptomatic. He therefore required hernia repair. ¿ implant procedure: laparoscopic incisional herniorrhaphy with mesh prosthesis. [implant: gore® dualmesh® plus biomaterial, 1dlmcp03/13790870, 10cm x 15cm x 1mm thick, oval] implant date: (b)(6) 2015 [hospitalization dates unknown]. (b)(6) 2015: (b)(6) medical center. (b)(6) assistant: (b)(6) anesthesia: general. Estimated blood loss: minimal. Complications: none. Specimens: none. Preoperative and postoperative diagnosis: incisional hernia. Classification surgical wound: clean. Description of hernia being treated: ¿after informed consent was obtained, the patient was taken to the operating room, laid in supine position, placed under general endotracheal anesthesia. Abdomen was prepped and draped in the usual sterile fashion. Skin was infiltrated with 0. 5% marcaine. A 5 mm optical trocar was inserted in the left upper quadrant. After, insertion, the abdomen was insufflated with carbon dioxide to 15 mmhg. A second port was then placed in the left lower quadrant. This was a 5 mm port. The hernia defect was identified _____ [sic] at the umbilicus. ¿ implant size and fixation: ¿a 10 x 15 piece of gore dualmesh was obtained. Fascial sutures were placed equal distance apart around the periphery of the mesh. It was then rolled and placed into the abdomen. The transfacial sutures were then brought out through the abdominal wall through individual stab incisions using gore suture passer. It was appropriately positioned over the hernia defect with at least 4 cm of overlap on all sides. The transfacial sutures were then tied. The mesh was then secured around its periphery using absorbable laparoscopic tacks. These were placed approximately 1 cm apart around the entire periphery of the mesh. The operative field was then reevaluated and noted to be hemostatic. The carbon dioxide was evacuated from the abdomen. The ports were removed. Dermabond was then applied. The incision was closed using 4-0 vicryl in subcuticular fashion. Dermabond was applied. The patient tolerated the procedure well. He was then awakened and taken to the recovery room in stable condition. All sponge and instrument counts were correct at the end of the procedure. ¿ implant record: ¿mesh dual plus 10 x 15. Type: implant. Qty: 1. Model #: 1dlmcp03. Lot #: 13790870. Site: abdomen. Mfg: gore. Expiration date: 2/2018. ¿ relevant medical information: (b)(6) 2019: (b)(6) medical center. (b)(6). Anesthesia: general. Estimated blood loss: less than 50 ml. Complications: none. Drains: none. Preoperative and postoperative diagnosis: incisional hernia. Procedure: exploratory laparotomy and lysis of adhesions. Indications: ¿small bowel obstruction with worsening bandemia. ¿ classified surgical wound: clean-contaminated. Procedure: ¿the patient was taken to the operating room and placed supine upon the operating room table, at which time general anesthesia was induced. Foley catheter was placed. The patient's abdomen was prepped and draped in the usual sterile fashion. Abdomen was entered through a lower midline incision and it was extended up the side and beyond the umbilicus. Care was taken while opening the mesh. Upon entering the abdomen, i found an adhesive band to the lower left corner of the mesh, that had the bowel wrapped around it. I divided this band and continued opening up. He had a large amount of adhesions to the right side of the mesh, that i felt we had to mobilize to make sure that all was clear. I opened up across his previously placed floor mesh and was able to free the abdominal wall completely. The bowel was viable throughout its course. I then ran the bowel proximal to distal and back distal to proximal, then proximal to distal one last time. All adhesions were freed. The bowel had no enterotomies and was completely viable throughout its course. There was already matriculation of enteral contents distally through the bowel. The patient's abdomen was copiously irrigated with warm normal saline. Hemostasis was checked for and found to be excellent. The patient's abdomen was then closed using interrupted smead-jones closure of 0 prolene suture, to make sure that the mesh was reapproximated well, subcutaneous tissue was copiously irrigated with warm normal saline. Skin was closed with clips. Sterile dressing was applied. Tap block was instilled per anesthesia, and the patient was awakened from anesthesia and taken to the recovery room in stable condition. ¿ explant preoperative complaints: (b)(6) 2019: (b)(6) medical center. (b)(6). Indication: infected abdominal wall mesh with ventral hernia. Explant procedure: removal of infected abdominal wall mesh. Primary repair of incisional hernia. Explant date: (b)(6) 2019 (hospitalization dates unknown). (b)(6) 2019: (b)(6) medical center. (b)(6). Anesthesia: general. Estimated blood loss: less than 100 ml. Complications: none. Drains: none. Preoperative and postoperative diagnosis: infected abdominal wall mesh with ventral hernia. Classified surgical wound: dirty and/or infected. Procedure: ¿the patient was taken to the operating room and placed supine upon the operating room table, at which time general anesthesia was induced. The patient's abdomen was prepped and draped in the usual sterile fashion. Abdomen was entered through his previous midline incision under toupe magnification. The abdominal wall was slowly and carefully entered and dissected free. I found obvious purulence surrounding the gore-tex mesh in the midline. This was slowly and carefully dissected free, taking care not to injure the abdominal wall viscera. I mobilized the inflammatory plate deep to the mesh and resected most of this. There was a portion of it that was too adherent to the small bowel to resect, and so i left it adherent and just trimmed it off. The bowel was completely viable throughout the abdomen and was run proximally and distally with no evidence of obstruction or problems or enterotomy being seen. I resected the umbilicus where the majority of his herniation and the infection was. I then closed the abdominal wall using interrupted figure-of-eight sutures of heavy weight prolene. This gave a good abdominal wall closure. The subcutaneous tissue was copiously irrigated with warm normal saline. The skin was loosely approximated, leaving gaps for drainage. Wound vac sponge was placed through this and wound vac was placed on the abdominal wall. This was connected to suction. Anesthesia then placed a tap block. The patient was extubated and taken to the recovery room in stable condition. ¿ pathology report: none provided. Relevant medical information: (b)(6) 2020: (b)(6). Assistants: (b)(6). Preoperative and postoperative diagnoses: small bowel obstruction. Procedure: exploratory laparotomy and lysis of adhesions. Anesthesia: general. Estimated blood loss: none. Specimens: none. Complications: none. Indications: ¿this is a (b)(6) m [male] with history of prior abdominal surgeries including umbilical hernia repair with mesh, subsequent sbo [small bowel obstruction] and exploratory laparotomy. Presented to ed with 1 day of pain. Ct scan concerning for closed loop. Focal tenderness over area of concern on imaging. Plan to proceed to or for ex lap given concern for bowel ischemia. ¿ findings: ¿viable small bowel. Few scattered adhesions, primarily in the left lower quadrant and under umbilical mesh. Point of constriction from adhesive band. ¿ procedure: ¿the patient was brought to the operating room and general anesthesia was induced. The patient was placed in supine position. The abdomen was prepped and draped in a sterile fashion. A timeout was performed and antibiotics were confirmed. A midline periumbilical laparotomy was made, and the abdomen was entered above the prior laparotomy scar. There are adhesions between a loop of decompressed small bowel and the umbilical mesh - this was taken down without injury to the bowel. There were a few scattered adhesions throughout the abdomen that were easily disrupted as i mobilized the bowel out of the abdomen. The small bowel was run from lot [ligament of treitz] to terminal ileum, and all was viable. There was transition point in the mid/distal jejunum and evidence of prior focal external compression of the bowel, likely from an adhesive band. No definitive second proximal transition point was identified. The bowel was reduced into the abdomen. The omentum was freed from the right side wall to allow coverage of the bowel beneath our incision. The abdominal wall fascia was closed with #1 pds suture in running fashion. The skin was closed with staples. Counts: correct. I was present for the entire operation as dictated. Post-op condition: stable. Post-op disposition: pacu [post anesthesia care unit ]. ¿ a potential relationship, if any, between the alleged injuries or complications and the gore device has not been established at this time based on available information.   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.
 
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Brand NameGORE® DUALMESH® PLUS 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
jorja nackard
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key12715109
MDR Text Key283829644
Report Number3003910212-2021-01308
Device Sequence Number1
Product Code FTL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K063435
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2018
Device Model Number1DLMCP03
Device Catalogue Number1DLMCP03
Was Device Available for Evaluation? No
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2015
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: 10/28/2021 Patient Sequence Number: 1
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