MAUDE Adverse Event Report: LIFECELL UNKNOWN ARTIA; MESH, SURGICAL

Catalog Number UNK ARTIA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

The device has been returned and is pending analysis.Based on the information reported, including no identification of the relevant lot number, a relationship between the event and strattice cannot be determined.Strattice as a contributing factor cannot be ruled out.Multiple attempts were made to gather additional information; however to date, no further information has been obtained.The lot number remains unknown; therefore internal investigation into the event could not be performed.If additional information is reported, a follow up adverse event report will be submitted.No further actions are required as a nonconformance could not be confirmed.

Event Description

It was reported that there was an arita extrusion.Device was explanted and returned.

Manufacturer Narrative

Device evaluation: microscopic description: a) an a-cellular collagen graft material is seen without cellular incorporation and with collections of bacterial colonies at the edges of the tissue.The tissue edges also show a fine layer of fibrin with scattered acute leukocytes (pmn's) within the fibrin.B&b bacterial stain highlights the bacterial colonies; gridley fungal stain is negative for organisms.Vvg elastin stain shows elastin fibers consistent with porcine origin.B) a tiny core of fibrinous exudate is seen, containing bacterial colonies and acute inflammatory cells at the edge.

Event Description

It was reported that there was an arita extrusion.Device was explanted and returned.

• Brand Name: UNKNOWN ARTIA
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• MDR Report Key: 8824026
• MDR Text Key: 152116177
• Report Number: 1000306051-2019-00103
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K142326
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ARTIA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention