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 Hematoma (1884); Necrosis (1971); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Ref.Initial reporter: corresponding author and associated institution.This mdr is being reported as an individual event type for serious injury due to the medical and surgical intervention to treat the superficial infections, necrosis and hematoma.As reported in the article, there were no septic incidents or readmissions for intravenous antibiotic treatment.It was not specified if any of the strattice devices were removed for the necrosis or hematoma complications.Lifecell has made multiple attempts for additional information, including relevant lot numbers.To date no additional information has been received.The lot numbers associated with these events remain unknown; therefore an internal investigation could not be performed.Based on the reported information, a relationship between the events and the strattice devices cannot be determined.If additional information is received, a follow up report will be filed.

Event Description

During a device alert literature review, an article titled "prophylactic nipple-sparing mastectomy and direct-to-implant reconstruction of the large and ptotic breast: is preshaping of the challenging breast a key to success?" was identified which reported a study of patients with large, ptotic breasts requesting a prophylactic mastectomy with immediate breast reconstruction from december of 2013 to december of 2015 that were offered a two-stage procedure: a preshaping mastopexy/reduction followed by a delayed nipple-sparing mastectomy/direct-to implant reconstruction.Within the study period, the two-stage procedure was performed in 22 women with large, ptotic breasts who opted for a bilateral risk-reducing mastectomy and immediate breast reconstruction.The median age of the patients was 46 years (range, 26 to 62 years).Known risk factors and comorbidities, diabetes and hypertension, and smoking habits were registered.An 8 x 16 cm sheet of strattice was used.The primary outcome measure was the number of partial and total nipple necroses and registered all complications encountered and the long-term result of achieved or failed reconstruction.Two patients had reoperations under general anesthesia, one because of hematoma and one because of fat necrosis.Five patients had minor complications, two with small wound dehiscence and three with superficial infection/redness treated with antibiotics.All red breasts were treated with antibiotics regardless of other signs, and there were no septic incidents or readmissions for intravenous antibiotic treatment.

• 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: 7494187
• MDR Text Key: 107586849
• Report Number: 1000306051-2018-00064
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K070560
• 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

• Date FDA Received: 05/08/2018
• 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
• Date Manufacturer Received: 04/09/2018
• 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
• Treatment: NO INFORMATION
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR