MAUDE Adverse Event Report: UNKNOWN STRATTICE; MESH, SURGICAL

Catalog Number UNK STRATTICE

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

During a literature review performed by medical safety, an article titled "browse: a multicentre comparison of nine year outcomes in acellular dermal matrix based and complete submuscular implant-based immediate breast reconstruction-aesthetics, capsular contracture and patient reported outcomes" was identified as the new full publication from the previous article "the long-term outcomes of the browse multicentre cohort study comparing strattice¿-assisted implant based reconstruction and submuscular reconstruction".The full article reports additional information that this was a multi-centre, retrospective cohort study comparing long-term outcomes in patients who underwent immediate ibbr using adm (sub pectoral) or a submuscular technique.Female patients, who had undergone immediate ibbr from january 2009 to december 2014, with a minimum of two years follow-up were recruited.The study recruited 117 (52 bilateral) patients who underwent 169 adm reconstructions, and 49 (16 bilateral) patients who underwent 65 submuscular reconstructions (fig.1).A further 70 returned the breast-q questionnaire only.In the adm group, 72 were risk-reducing mastectomies (rrm) with 26 rrm in the submuscular group.The median age of patients in the adm group and submuscular group appeared similar (54 years (range 29-75 years), and 56 years (range 41-79 years) respectively).However, there were 15 (13%) women aged <40 in the adm group but no women <40 in the submuscular group.There was a trend for more smokers in the submuscular group (6.8% vs 16.3%).The median follow-up was 62 months (range 29 months - 113 months) in the adm group and 76 months (range 38 months - 111 months) in the submuscular group.Of the 169 adm reconstructions assessed by the research clinician, 17 (10.1%) were graded baker 3/4 compared to 6 (9.2%) of the 65 submuscular reconstructions.In the adm group 6 (3.6%) of those graded with a baker 1 or 2 capsule at the time of the study had previously undergone surgery to correct capsular contracture compared to 8 (13.6%) in the submuscular group.This gives an estimated total rate of capsular contracture (baker 3/4 or previous surgery for capsular contracture) in the adm group of 13.6% and 21.2% in the submuscular.This is an absolute risk reduction of 8% in favour of adm.The new full publication reports additional complications that were not previously reported in the initial article.In the adm group 67 (57.3%) patients experienced a complication compared to 30 (61.2%) in the submuscular group.In the adm group, of the 23 (13.6%) reconstructions which had capsular contracture, 11 (48%) experienced a complication prior to developing capsular contracture; 8 were treated for suspected infection, 3 had wound dehiscence, 1 had evacuation of haematoma, 3 had a seroma (one required aspiration) and two had implant loss with revision of reconstruction.The rate of capsular contracture if there had been a complication was 14.1% compared to 13.2% if there had not been a complication.In the submuscular group 14 (21.2%) reconstructions had capsular contracture, 11 (79%) experienced a complication prior to developing this.Three had a wound dehiscence and ten had a seroma (seven required aspiration).The rate of capsular contracture if there had been a complication was 33.3% compared to 9.1% if there had not been a complication.Previous or adjuvant radiotherapy was administered in 14 (8.4%) of the adm reconstructions, seven (50%) of these developed capsular contracture.In the submuscular group six (9.2%) had received radiotherapy, one (16.7%) developed capsular contracture.Patient determined baker grade was compared to clinician assessment.In the adm group, 48 (28.4%) were upgraded, 92 (54.4%) graded the same and 29 (17.2%) were downgraded by the patient.In the submuscular group 22 (33.8%) were upgraded by the patient, 32 (49.2%) graded the same and 11 (17%) downgraded.In both the adm and submuscular group the agreement between clinician and patient of baker grade was considered ¿fair¿ using both a kappa statistic (0.234 and 0.219 respectively) and weighted kappa (0.352 and 0.334).The overall conclusion reported that this study provides evidence of improved aesthetic outcome and reduction in capsular contracture with adm reconstruction when compared to submuscular, consistent over long-term followup.The other previously reported complaint of capsular contracture with this article was captured under pr (b)(4).

Manufacturer Narrative

Corresponding author and institution: this literature review is being reported as an individual event type in an abundance of caution as serious injury due to the reported infections with intervention.It is unknown if the strattice devices were explanted.Multiple attempts were made to gather additional patient and procedure specific information including lot numbers and device dispositions.To date, the lot numbers associated with these events remain unknown; therefore an internal investigation into the device history records could not be performed.No devices were returned to lifecell for evaluation.A relationship to the strattice could not be determined.If additional information is received, a follow up report will be submitted.No further actions are required as a nonconformance could not be confirmed.

• Brand Name: UNKNOWN STRATTICE
• Type of Device: MESH, SURGICAL
• Manufacturer Contact: christopher belle ; 1 millennium way; branchburg, NJ 08876 ; 9089471470
• MDR Report Key: 13172056
• MDR Text Key: 288662606
• Report Number: 1000306051-2021-03075
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• 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
• Date Manufacturer Received: 12/08/2021
• 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
• Patient Age: 54 YR