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

Catalog Number UNK STRATTICE

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

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Corresponding author and institution.This literature review is being reported as an individual event type for the serious injuries related to the patients with skin blister/wound dehiscence/exposure of adm that required revision and for the patient that had the adm removed due to failure to integrate as well as the patients with infection requiring outpatient treatment.The remaining complications for redness, seroma, nipple necrosis and re-excision either did not result in serious injury or were determined not to be device related per the investigator.Follow up attempts are being made to gather subject data and strattice lot numbers for the events.To date, the lots numbers associated with these events remain unknown; therefore an internal investigation could not be performed.No devices were returned to lifecell for evaluation.A relationship to the strattice could not be determined; however, it should be noted that the strattice was reported to be incorporated into the patient's native tissues for those with skin blister/wound dehiscence/exposure and therefore the device performed as expected in those cases.If additional information is received, a follow up report will be submitted.

Event Description

The investigator initiated trial publication by dr.Fredrik lohmander titled "implant based breast reconstruction with acellular dermal matrix" was received which reported all final results from the randomized, controlled trial in sweden and the uk for ibbr with strattice.The publication contains additional saes that were not previously reported to lifecell at the time of the study/events.Upon follow up with the investigator for clarification, the additional saes include: six patients with skin blisters /wound dehiscence/ exposure of adm or implant.Per the investigator, patients had wound healing problems.Four of these six required reoperation with wound revision and a concomitant exchange of the (breast) implant.The adm was removed in one case where it had not integrated.In the other revision cases, the adm was judged as fully incorporated into the native tissues.The additional two patients in the adm group were treated conservatively in the out-patient setting eventually resulting in one implant loss.1 patient with redness that was previously identified with no device relationship.There was no sae for this event.2 patients with nipple necrosis with no relation to the device (matrix).14 patients with seromas, judged as self limited.Those not resolved were aspirated.9 patients with infection and outpatient treatment; 1 one of these was previously identified with no device relationship.1 patient with re-excision after mastectomy with no relation to the device (matrix).

• Brand Name: UNKNOWN STRATTICE
• 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 ; 9089471100
• MDR Report Key: 8078029
• MDR Text Key: 127543355
• Report Number: 1000306051-2018-00143
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial

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 STRATTICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/16/2018
• 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
• Patient Outcome(s): Required Intervention