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

Model Number 0010302

Device Problem Defective Device (2588)

Patient Problems Death (1802); Fistula (1862); Unspecified Infection (1930)

Event Date 11/20/2016

Event Type  Death  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. We have contacted the initial reporter to request additional information including patient information, copies of medical information/records and death certificate/autopsy report and to request return of the device for evaluation. A manufacturing review was performed which found no anomalies during the manufacturing process of the device. The information provided alleges the patient experienced infection, pain, fistula, adhesions, abscess and death. Adhesions, infection and fistula are listed as known possible adverse reactions in the instructions-for-use. In regards to infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the patch. An unresolved infection may require removal of the device. " with the current information available, no definitive conclusion can be made. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned to manufacturer.

Event Description

The following was reported to davol by the patient's attorney: on (b)(6) 2010 - the patient underwent surgery with implant of a bard ventralex hernia patch for the repair of an incisional ventral hernia. On (b)(6) 2015 - patient had abdominal pain, nausea and vomiting and she was admitted to the hospital the next day. Over the next few months the abdominal pain continued. On (b)(6) 2015 - the patient was diagnosed with infected hernia mesh and the doctors determined that the ventralex hernia patch needed to be removed. On (b)(6) 2015 - patient underwent surgery to remove an infected hernia mesh, including a transverse colon resection and a small bowel resection because the hernia mesh was densely adhered to the patient's colon and small intestine. On (b)(6) 2016 - the patient died, the attorney alleges that the patient's death was caused in whole or in part by complications from the infected hernia mesh which was caused, or contributed to be caused, by the ventralex hernia patch. The attorney's legal claim alleges the patient experienced severe and permanent injury, revision surgery including take down of an enterocutaneous fistula, removal of infected hernia mesh, transverse colon resection and small bowel resection, post surgical chronic abdominal fistula, cachexia and chronic peritonitis, abdominal abcesses and death.

• Brand Name: VENTRALEX
• 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: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6771910
• MDR Text Key: 82008609
• Report Number: 1213643-2017-00494
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K021736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER,OTHER
• Reporter Occupation: ATTORNEY
• Type of Report: Initial
• Report Date: 08/07/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/07/2017
• Is This An Adverse Event Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 05/28/2015
• Device MODEL Number: 0010302
• Device Catalogue Number: 0010302
• Device LOT Number: HUUD1542
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 05/06/2010
• 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: 08/07/2017 Patient Sequence Number: 1