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 Capsular Contracture (1761); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

This mdr is being reported as an individual event type as serious injury due to the surgical intervention to explant the device.It should be noted that the nonincorporation of the strattice device was an incidental finding secondary to the capsular contracture.Follow up was performed with the corresponding author for additional information, including relevant lot numbers.As per the author, questions were sent to (b)(6).To date, no additional information has been provided.The article reported that non-integration of adm in breast reconstruction is possible and might be associated with prolonged and severe seroma formation and early formation of capsular contraction.The lot number associated with this event remains unknown; therefore an internal investigation could not be performed.Based on the reported information and conclusions of the article, the event is unlikely related to the strattice device and likely related to patient factors.No further actions are required; a nonconformance could not be confirmed.If additional information is received, a supplemental report will be submitted.

Event Description

During a literature review, an article titled "non-integrated acellular dermal matrix in breast reconstruction: a case report" was identified which reported a case of a 51 year old female patient with a history of right breast lobular carcinoma in situ, lumpectomy and sentinel node procedure and post op radiation therapy in 2011.In 2014, due to a relapse, the patient underwent nipple sparing mastectomy and primary reconstruction to the right breast with strattice.Post-op, the patient had undergone reoperation due to a seroma caused by a plugged drain tube.Twelve months after reconstruction, the patient underwent corrective surgery with lipofilling due to significant asymmetry; however developed capsular contracture.In 2016, the patient had an additional corrective surgery with removal of the cap con and replacement of the implant.Intraoperatively, the nonintegrated adm (strattice) along side 40ml of seroma was found.The adm was removed and implant was exchanged.Histopathology of the adm showed no signs of neoangiogenesis or ingrowth of the patient's own cells.No pathology was found in the seroma or capsule and no microbiological agents were found.Conclusion reported that this case report demonstrates that non-integration of adm in breast reconstruction is possible and might be associated with prolonged and severe seroma formation and early formation of capsular contraction.The article also reports that the manufacturer of the adm was contacted regarding possible material fault.The manufacturer response was seroma as the main reason for the nonintegration.A previous complaint investigation file could not be identified for this event.

• 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: 7573407
• MDR Text Key: 110364302
• Report Number: 1000306051-2018-00076
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• 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: 05/09/2018
• 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
• Patient Age: 51 YR