MAUDE Adverse Event Report: AZIYO BIOLOGICS INC. CANGAROO ENVELOPE; MESH, SURGICAL - FTM

Model Number	CMCV-009-MED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review of the cangaroo envelope device history record for the reported lot shows that all packaged and labeled units were quality released to distribution on 04/17/2020 having met all internal qc acceptance requirements.All sterilization processing records and bioburden testing indicate a successful sterilization cycle and passing results of product lal and sterility samples allowing the subassembly lot to be released for further packaging and labeling having met all criteria for release.There were no non-conformances during manufacturing or sterilization potentially impacting the final acceptance of this manufacturing lot.In lieu of a request for the oem supplier dhr review, it is noted that aziyo processes the non-sterile envelope materials including cutting, suturing, packaging and sterilizing the product.The reason for the explantation of the aziyo device is was related to a tuning issue with the implanted cied and device leads resulting in high pacing thresholds which would potentially decrease battery life.A replacement device and cangaroo envelope were implanted following removal.Device tuning issues are a recognized procedural complication associated with cied implantation, and not associated with usage of the cangaroo envelope.Should aziyo receive any additional details related to this event, a supplemental report will be filed.
Event or Problem Description
It was reported by aziyo biologics' business partner boston scientific, that a cangaroo envelope (model cmcv-009-med lot #m20d1137) was used with a boston scientific device (model # / serial # unknown) and implanted on (b)(6) 2020.On (b)(6) 2020 the device and cangaroo pouch were explanted due to a lead revision procedure required due to high pacing thresholds.A new device and cangaroo envelope were implanted.This issue was reported to aziyo biologics by boston scientific on 10/22/2020 and further information received on 11/18/2020.

• Brand Name: CANGAROO ENVELOPE
• Common Device Name: MESH, SURGICAL - FTM
• Manufacturer (Section D): AZIYO BIOLOGICS INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 10861895
• Report Number: 3005619880-2020-00095
• Device Sequence Number: 3949473
• Product Code: FTM
• UDI-Device Identifier: 00859389005034
• UDI-Public: 00859389005034
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K192616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: CMCV-009-MED
• Device Lot Number: M20D1137
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BSC CIED (MODEL# / SERIAL# - UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention