MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION BILAYER MATRIX WOUND DRESSING; BMWD

Catalog Number XXX-BWM

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

This is 1 of 2 reports.Other mfg report number: 1121308-2020-00041.The journal of the american society of plastic surgeons (march 2020) published: "comparative effectiveness analysis of complex lower extremity reconstruction: outcomes and costs for biologically based, local tissue rearrangement, and free flap reconstruction." purpose: to evaluate the effectiveness and cost of three common surgical reconstructive modalities.Methods: all adult subjects with lower extremity wounds who received bilayer wound matrix, local tissue rearrangement, or free flap reconstruction were retrospectively reviewed (from 2010 to 2017).Cohorts¿ comorbidities and wound characteristics were balanced.Graft success at 180 days was the primary outcome; readmissions, reoperations, and costs were secondary outcomes.Results: a total of five hundred one subjects (166 matrix = ¿integra¿, 190 rearrangement, and 145 free flap patients) were evaluated.Matched subjects (n = 312; 104/group) were analyzed.Reconstruction success at 180 days for matrix, local tissue rearrangement, and free flaps was 69.2 percent, 91.3 percent, and 93.3 percent (p < 0.001), and total costs per subject were $34,877, $35,220, and $53,492 (p < 0.001), respectively.Median length of stay was at least 2 days longer for free flaps (p < 0.0001).Readmissions and reoperations were greater for free flaps.Local tissue rearrangement, if achievable, provided success at low cost.Free flaps were effective with large, traumatic wounds but at higher costs and longer length of stay.Matrices successfully treated older, obese patients without exposed bone.There were 45 readmissions in the bilayer wound matrix group.With regard to the entire cohort, the majority of reoperations were due to debridement (bilayer wound matrix, n = 35).Bilayer wound matrix was effective in about 70 percent of patients but successfully treated older, obese patients without exposed bone at minimal expense.Adverse event to include the following since no specific patient demographics were provided ¿ 35 debridement¿s and 15 amputations - there were 45 hospital readmissions, 69 reoperations, of which 35 of those were for debridement.There were 45 readmissions in the bilayer wound matrix group.With regard to the entire cohort, the majority of reoperations were due to debridement (bilayer wound matrix, n = 35).Bilayer wound matrix was effective in about 70 percent of patients but successfully treated older, obese patients without exposed bone at minimal expense.Conclusion: data presented in this large, multi-institutional study highlight the relative clinical benefits to specific lower extremity reconstruction based on patient and wound characteristics.We effectively compare three treatment modalities using an advanced matching technique.We demonstrated that free flap reconstruction is a successful reconstructive option; however, it leads to longer length of stay, increased numbers of readmissions and reoperations, and high costs.Local autologous tissue rearrangement, if achievable, provides successful coverage at minimal costs and decreased readmissions and reoperations.Bilayer wound matrix can be effectively used in certain patient populations while reducing costs and decreasing length of stay.Doi: 10.1097/prs.0000000000006589.

Manufacturer Narrative

The bilayer matrix wound dressing was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: BILAYER MATRIX WOUND DRESSING
• Type of Device: BMWD
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• MDR Report Key: 10399941
• MDR Text Key: 202735967
• Report Number: 1121308-2020-00039
• Device Sequence Number: 1
• Product Code: KGN
• Combination Product (y/n): N
• PMA/PMN Number: K021792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-BWM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1