MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 XENMATRIX; PORCINE SURGICAL MESH

Catalog Number 1162025

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Fistula (1862)

Event Date 03/08/2015

Event Type  Injury  

Manufacturer Narrative

As reported, post implant of the xenmatrix, the patient was diagnosed with abscess, enterocutaneous fistula and underwent reoperation to treat the fistula.The clinician has assessed the patient¿s postoperative course of abscess as definitely related to the study device and not related to the procedure.The clinician has assessed the patient¿s postoperative course of enterocutaneous fistula as possibly related to the study device and not related to the procedure.However, based on the information provided, no conclusion can be made.Fistula is a known inherent risk of surgery and listed as a possible complication in the instructions-for-use (ifu) supplied with the device.Review of manufacturing records confirms product was manufactured to specification.This mdr represent the aes of abscess and fistula (device #2).An additional mdr was submitted to represent the ae of hernia recurrence (device #1).

Event Description

Alleged per clinical trial (b)(4): on (b)(6) 2014, the subject patient underwent multiple recurrent open incisional transverse hernia repair, during which two xenmatrix surgical grafts were trimmed and placed in underlay fashion on the intra-peritoneal region using a suture.Fascia was completely closed with vicryl suture in interrupted stitch technique and full closure was achieved with sutures.Concomitant procedure abdominal wash out was performed.The patient was discharged from the hospital on (b)(6) 2014.On (b)(6) 2015, the patient was diagnosed with an abscess and was admitted into the hospital.The patient was discharged to home on (b)(6) 2015.On (b)(6) 2015, the patient was diagnosed with an enterocutaneous fistula and was admitted into the hospital on (b)(6) 2015.During this hospital stay, the patient underwent a surgical procedure (details not provided).The patient was discharged from the hospital on (b)(6) 2015.The ae, abscess is clinically assessed to be not related to the procedure and definitely related to the study device.This ae, enterocutaneous fistula is clinically assessed to be not related to the procedure and possibly related to the study device.These aes have been assessed as a serious adverse event of moderate severity and has resolved.The reported adverse event met the definition of an sae (serious adverse event) and does not meet the definition of uade (unlisted adverse event).

Event Description

Alleged per clinical trial dvl-he-020: on (b)(6) 2014, the subject patient underwent a multiple-recurrent open incisional transverse hernia (25 cm x 20 cm) repair procedure, during which two xenmatrix surgical grafts (device #1 & device #2) were trimmed and placed in underlay fashion intra-peritoneally using sutures.Fascia was completely closed with vicryl suture in interrupted stitch technique and full closure was achieved with sutures.Concomitant procedure included lysis of adhesion(s).The patient was discharged from the hospital on (b)(6) 2014.On (b)(6) 2015, the patient was diagnosed with recurrent incisional hernia.On (b)(6) 2015, the patient underwent reoperation to repair the hernia, during which another xenmatrix surgical graft (device #3) was implanted.The patient was discharged from the hospital on (b)(6) 2015.On 08-march-2015, the patient was diagnosed with an abscess and was admitted into the hospital.The patient was discharged on (b)(6) 2015 and the abscess resolved on (b)(6) 2015.On (b)(6) 2015, the patient was diagnosed with an enterocutaneous fistula and was admitted into the hospital on (b)(6) 2015 and underwent a surgical procedure.Both the abscess and fistula were noted to be associated with the xenmatrix implanted on (b)(6) 2015 (device 3).The ae, abscess is clinically assessed to be not related to the procedure and definitely related to the study device.This ae, enterocutaneous fistula is clinically assessed to be not related to the procedure and possibly related to the study device.These aes have been assessed as a serious adverse event of moderate severity and has resolved.The reported adverse event met the definition of an sae (serious adverse event) and does not meet the definition of uade (unlisted adverse event).

Manufacturer Narrative

As reported, post implant of the xenmatrix, the patient was diagnosed with abscess, enterocutaneous fistula and underwent reoperation to treat the fistula.The clinician has assessed the patient¿s postoperative course of abscess as definitely related to the study device and not related to the procedure.The clinician has assessed the patient¿s postoperative course of enterocutaneous fistula as possibly related to the study device and not related to the procedure.However, based on the information provided, no conclusion can be made.Fistula is a known inherent risk of surgery and listed as a possible complication in the instructions-for-use (ifu) supplied with the device.Review of manufacturing records confirms product was manufactured to specification.Addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the corrected event information details regarding the implant of device #2 and corrected implant date.This supplemental mdr represent the ae of abscess and fistula (device #3).Additional mdr was submitted to represent the ae of hernia recurrence associated with device #2 and additional supplemental mdr was submitted to represent the ae of hernia recurrence associated with device #1.Note: section a through f - the information provided by bd 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 bd.H3 other text : not returned - remains implanted.

• Brand Name: XENMATRIX
• Type of Device: PORCINE SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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 ; 8005566756
• MDR Report Key: 15151071
• MDR Text Key: 297129848
• Report Number: 1213643-2022-00561
• Device Sequence Number: 1
• Product Code: FTM
• UDI-Device Identifier: 00801741031465
• UDI-Public: (01)00801741031465
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2016
• Device Catalogue Number: 1162025
• Device Lot Number: HUYD1196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 84 KG