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

Catalog Number 1MYM18

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Fever (1858); High Blood Pressure/ Hypertension (1908); Pain (1994); Swelling (2091); Burning Sensation (2146); Hernia (2240); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).It should be noted that the gore mycromesh® biomaterial instructions for use mentions the following warning, 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.¿.

Event Description

It was reported to gore that a patient alleges to have underwent repair of his left inguinal hernia on (b)(6) 2009.The complaint states that ¿on information and belief, plaintiff alleges that a tension-free gore tex patch [sic] was used as part of the surgery.¿ the complaint states that ¿on or about (b)(6) 2014, plaintiff¿s [sic] underwent a further surgery to repair a large, right inguinal hernia.On information and belief, plaintiff alleges that a gore micromesh [sic] ref.# 1m4m18 lot # 12039341 (¿gore micromesh¿) was used as part of this surgery.¿ it was reported that the ¿plaintiff alleges that the above second procedure (right side on (b)(6) 2014) failed within 8-10 weeks, thereby requiring a third surgery.¿ the complaint alleges that ¿on or about (b)(6) 2014, plaintiff¿s right inguinal hernia was repaired, again.This time, plaintiff¿s surgery involved the placement of a covidien parietex mesh [non-gore device].¿ ¿in addition, plaintiff alleges that the covidien mesh was secured with a bard sorbafix absorbable fixation system [non-gore device].¿ it was reported that ¿in early 2017, during plaintiff¿s annual routine physical¿plaintiff informed his physician that he had been experiencing pain and a tightness/pulling sensation in the area of his previous two (2) hernia repair surgeries.In addition to these symptoms, plaintiff reported a bulge in the area of his surgeries.In response to plaintiff¿s report and after examination, plaintiff¿s physician ordered a ct scan.¿ the complaint states that ¿on or about (b)(6) 2017, a radiology report (in connection with the above ct scan) referenced ¿a mildly enlarged mesenteric lymph node¿, an ¿enlarged central mesenteric lymph node¿, as well as ¿mild enlarged periaortic and common iliac lymph nodes.¿ on or about mid-(b)(6) 2017, plaintiff met with and was informed by his primary care physician that there were enlarged lymph nodes indicative of ¿metastatic disease or lymphoma.¿¿ the complaint alleges that ¿during the ensuing weeks (approximately 6 weeks), plaintiff underwent multiple tests requiring a number of visits to the va.During this time, plaintiff expected the worst: in his mind and based on the ct scan and his physician¿s discussion, he likely was suffering from cancer and, particularly frightening, the cancer had spread to vital organs.¿ ¿during this period, plaintiff underwent a series of blood tests, gi scopes, and a number of medical appointments.¿ it was reported that ¿on or about (b)(6) 2017, and after the visits, testing, and waiting, plaintiff was informed by his primary care physician that his leukemia/lymphoma test came back ¿negative¿ and that he was cancer free.On or about (b)(6) 2017, plaintiff underwent an endoscopy and, on or about (b)(6) 2017, a colonoscopy.In a discussion with his gastroenterologist, on or about (b)(6) 2017, and with the information that his lymph nodes were not cancerous, plaintiff queried the gastroenterologist about his condition and its cause.The gastroenterologist opined that it was ¿the mesh.¿¿ the complaint states that ¿since (b)(6) 2017, and despite the ruling out of cancer, plaintiff has experienced a myriad of symptoms, including without limitation aches, pains, random bouts of fever, high blood pressure (for the first time in his life), an unexplained nerve/burning [sic[ pains in his testicles and groin, and a sharply diminished libido.Plaintiff has, since early 2018, lost 10-15 pounds for no apparent reason and has a decreased appetite.Plaintiff has also experienced back pain and fatigue.He now becomes winded and exhausted when taking out the trash or walking to the mailbox, tasks that he could previously do without an issue.Ct scans continue to show swollen lymph nodes, and plaintiff has a bulge on the right side of his abdomen, with a straining, pulling sensation from the area of the bulge to his right testicle with the slightest amount of exertion.¿ the complaint alleges that ¿as a direct and proximate cause of the above, plaintiff sustained injuries, including without limitation physical injury and, among other things, extreme anguish, and pain and suffering¿¿ additional, event specific information was not provided.

Manufacturer Narrative

Confirmed with outside psg that on october 19, 2018 the claim was withdrawn, and the alleged product complaint is no longer being pursued at this time.No further investigation is required at this time.This event will be closed.Conclusion code 4316: appropriate term/code not available is being used for "withdrawn complaint.¿.

Manufacturer Narrative

All previous patient codes 1994, and 3191 other code for "second procedure right side on (b)(6) 2014 failed within 8-10 weeks" were reported based on the original complaint and are no longer applicable per gore¿s investigation.Updated final codes.Conclusion code 4316: appropriate term/code not available used for "withdrawn complaint".No further investigation is required at this time.Based upon gore¿s investigation there is no available information that reasonably suggests that a gore device may have caused or contributed to death, serious injury or reportable malfunction, and is no longer considered reportable.This event will be closed as no problem detected.

• Brand Name: GORE® MYCROMESH® BIOMATERIAL
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7533016
• MDR Text Key: 108876600
• Report Number: 3003910212-2018-00024
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K931150
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 1MYM18
• Device Lot Number: 12039341
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention