MAUDE Adverse Event Report: SYNOVIS SURGICAL INNOVATIONS VERITAS COLLAGEN MATRIX; MESH, SURGICAL

Device Problems Detachment Of Device Component (1104); Sticking (1597)

Patient Problem No Information (3190)

Event Date 03/19/2014

Event Type  Injury  

Event Description

It was reported to baxter that a patient experienced great deal of abdominal pressure after surgery in which veritas was used.The customer stated they placed a wound vac with veritas to close the wound.On (b)(6) 2014, it was noticed the veritas was partially detached and was sticking to the valve.The customer stated they will have to do another wound vac change.It was noted that the surgeon is experienced in using veritas.No further information provided.

Manufacturer Narrative

(b)(4).Baxter medical assessment: while we cannot exclude that the implant has caused or contributed to the reported infection/wound healing disorder, multiple risk factors and alternative causes for infection such as: patient, and disease-related risk factors, and contaminated surgical wounds, use of other implants (sutures, staples), intra-operative contamination, diabetes mellitus or other associated pathologies have to be considered.Even if the batch review proves negative and the implant would have been non-contaminated until its surgical handling and application, due to the known characteristic of any implantable collagen (lot and product independent) to potentially augment the inflammatory and infectious response to surgical field contamination, we cannot rule out that the product may have contributed to the reported wound healing disorder complication.The veritas ifu adequately refers to this risk and the measures to be taken.(¿when clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic measures should be taken to manage the contamination/infection.¿) a follow-up report will be submitted upon receipt and evaluation of the manufacturer's investigation.

Event Description

Additional information received on (b)(4) 2014: patient recovered and was discharged for homecare.

Manufacturer Narrative

(b)(4).Baxter (b)(4) completed the investigation.Sample evaluation and batch review could not be performed as no sample or lot number were provided.No trend was identified.Per synovis, based on the information provided by the customer, the root cause cannot be determined.No further investigation is required as it is not possible to identify that the product was the cause of the issue.This case will be kept on file for trending purposes.

• Brand Name: VERITAS COLLAGEN MATRIX
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer (Section G): SYNOVIS SURGICAL INNOVATIONS; 2575 university ave. w; saint paul MN 55144
• Manufacturer Contact: kimberly crane ; one baxter way; westlake village, CA 91362 ; 8053723182
• MDR Report Key: 3722300
• MDR Text Key: 4306615
• Report Number: 2032282-2014-00057
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2014
• 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): Other