MAUDE Adverse Event Report: VERICEL MACI; CARTILAGE BIOMATRIX IMPLANT

Lot Number BB14223-21

Device Problem Leak/Splash (1354)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

Maci leaked [product complaint] : case narrative: case reference number (b)(4) is a spontaneous pqc (product quality complaint) case initially received from a cell therapy specialist on (b)(6) 2020 regarding maci implant leakage.On (b)(6) 2020, it was reported that maci implant leaked (lot number: bb14223-21, exp.Date: 02-apr-2020).This maci implant was sent back to vericel.On the same day, another maci (lot number: bb14223-22) was implanted in the knee of (b)(6) patient, for trochlea defect.No adverse event was reported.No further information was provided.Case comments: product complaint is listed by convention.Reportedly, maci implant leakage.Maci wasn't implanted.There were two potential risks associated with maci leakage: 1) use of potentially microbially contaminated implant could lead to joint infection, failure of the implant to integrate or delamination, and 2) drying of the implant due to excessive fluid loss, which could also lead to failure of the implant to integrate or delamination.This case is assessed as a 30-day medical device report due to the device malfunction and it will be expedited to the us fda.

• Brand Name: MACI
• Type of Device: CARTILAGE BIOMATRIX IMPLANT
• Manufacturer (Section D): VERICEL; 64 sidney street; cambridge MA 02139
• Manufacturer Contact: 64 sidney street; cambridge, MA 02139
• MDR Report Key: 9989813
• MDR Text Key: 240393507
• Report Number: 3002836339-2020-00005
• Device Sequence Number: 1
• Product Code: NCO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/02/2020
• Device Lot Number: BB14223-21
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR