MAUDE Adverse Event Report: LIFECELL STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM; MESH, SURGICAL

Catalog Number 1016002

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

Patient Problems Hernia (2240); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/07/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation and although a lot number was reported, the lot number is invalid and remains unknown; therefore, internal investigation could not be performed.Based on the reported information, a relationship between the event and strattice cannot be confirmed.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 a (b)(6) year old female underwent hernia repair surgery on (b)(6) 2010 with dr.(b)(6) who preformed the incarcaerated hernia repair in (b)(6) and placed strattice lot s10693-287.After the surgery, the patient returned to the hospital on (b)(6) 2015 and was diagnosed with an incarcerated hernia recurrence with strangulated bowel.The surgeon placed a second piece of strattice - lot sp10069-167 and performed the revision surgery.The patient returned to the hospital on (b)(6) 2019 and was diagnosed with a small bowel obstruction and the strattice mesh was balled up on the edges requiring removal of the mesh.It was not reported if both lots were explanted.This complaint investigation is associated to lot sp10069-167.

Manufacturer Narrative

Internal investigation into strattice lot: sp100169 included a review of the reported information, review of the device history records, and a review of the complaint history records.The investigation resulted in no remarkable findings, including no other complaints reported against the lot and no deviations or non-conformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.As of 04/27/2022, of the (b)(4) devices released to finished goods for lot: sp100169, (b)(4) have been distributed with 114 reported as implanted.Based on our internal review with no remarkable findings, a relationship between the strattice and this event could not be determined.No further actions are required as a nonconformance could not be confirmed.As reported in the initial: the device was not returned for evaluation and although a lot number was reported, the lot number is invalid and remains unknown; therefore, internal investigation could not be performed.Based on the reported information, a relationship between the event and strattice cannot be confirmed.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

This is follow up#1 to report updated information from legal on april 18, 2022 that stated the lots associated with this patient are s10736-118 (implanted on (b)(6) 2010) and sp100169-167 (implanted on (b)(6) 2015).This record is associated with sp100169-167.As reported in the initial: it was reported that a 37 year old female underwent hernia repair surgery on (b)(6) 2010 with dr.(b)(6) who preformed the incarcerated hernia repair in anchorage, ak and placed strattice lot: s10693-287.After the surgery, the patient returned to the hospital on (b)(6) 2015 and was diagnosed with an incarcerated hernia recurrence with strangulated bowel.The surgeon placed a second piece of strattice, lot: sp10069-167 and performed the revision surgery.The patient returned to the hospital on (b)(6) 2019 and was diagnosed with a small bowel obstruction and the strattice mesh was balled up on the edges requiring removal of the mesh.It was not reported if both lots were explanted.This complaint investigation is associated to lot: sp10069-167.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 10 X 16, FIRM
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer (Section G): LIFECELL; 1 millennium way; branchburg NJ 08876
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 12080571
• MDR Text Key: 269384303
• Report Number: 1000306051-2021-03010
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1016002
• Device Lot Number: SP100169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: NI.
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female