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

Model Number CMCV-009-MED

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2020

Event Type  Injury  

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 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
• Type of Device: MESH, SURGICAL - FTM
• Manufacturer (Section D): AZIYO BIOLOGICS INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• Manufacturer (Section G): AZIYO BIOLOGICS INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• Manufacturer Contact: michael hennick ; 1100 old ellis road; ste 1200; roswell, GA 30076 ; 4705144023
• MDR Report Key: 10861895
• MDR Text Key: 216963589
• Report Number: 3005619880-2020-00095
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: CMCV-009-MED
• Device Lot Number: M20D1137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/18/2020 Patient Sequence Number: 1

Treatment

BSC CIED (MODEL# / SERIAL# - UNKNOWN)