MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH

Catalog Number 5950008

Device Problems Signal Artifact/Noise (1036); False Positive Result (1227); Device-Device Incompatibility (2919)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

Based on the information provided a pet scan in that area of the ventralex st lit up the entire implant. It appears that the imaging anomaly was due to the implant at the site. There are reports in literature that the inflammatory process associated with mesh healing may mimic malignancy on pet. Plypropylene products, including hernia mesh such as ventraex st may light up on a pet scan due to higher uptake of the tracer. A review of the manufacturing records was performed and found that the lot was manufactured to specification. This emdr addresses the issue associated with imaging that was reported. An additional emdr was submitted to report the postoperative obstruction experienced by the patient. Should additional information be provided a supplemental emdr will be submitted.

Event Description

It was reported that the patient underwent a laparoscopic incisional hernia repair with ventralex st hernia patch on (b)(6) 2019. Post implant, the patient presented with a stricture in the small bowel which led to partial bowel obstruction, and underwent surgery. During the procedure, the surgeon encountered and removed dense like adhesions of the ventralex st to the bowel. Later, upon identifying a point of obstruction at the enterotomy site in the small bowel, the surgeon repaired the enterotomy and opened the stricture/obstruction. A small piece of bowel was sent to pathology; and the report stated metastatic poorly differentiated adenocarcinoma, possibly of pancreatic or cholangiocarcinoma. A work-up of the patient did not reveal any evidence of a primary tumor. A pet scan, however, ¿lit up¿ the entire mesh. The patient was referred to a surgical oncologist who considered removing the mesh. The implanting surgeon considered that pathology may be mistaking a ¿desmoplastic¿ response as cancer; the ¿desmoplastic¿ response being a reaction of the bowel to the mesh or the st coating. The surgeon also consulted a nuclear medicine physician who stated that most of the polypropylene products, including vascular grafts, light up on pet scans. The surgeon did not think that, the mesh by itself showing higher uptake of the tracer on the pet scan would be considered an ominous sign.

• Brand Name: VENTRALEX ST
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED 3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 10394180
• MDR Text Key: 202542416
• Report Number: 1213643-2020-07301
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 5950008
• Device Lot Number: HUDP1035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2019
• 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: 08/11/2020 Patient Sequence Number: 1