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

Model Number	CMCV-009-MED
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review of the aziyo biologics device/lot history record for the reported lot shows that all units were quality released to finished goods on 4/11/2019 having met all internal qc acceptance requirements and met criteria for manufacturing release.There were no non-conformances associated with the manufacturing lot.All sterilization records, and bioburden testing indicate successful sterilization process, and passing lal and product sterility results allowed the lot to be released having met all criteria for manufacturing release.The exact relationship to the device cannot be conclusively determined.It can be noted that culture results were negative.The final assessment from the ep team is that the pocket was not infected.However, focus was placed on the purulent exudate and they assume the patient had some type of non-infectious reaction to the pouch utilized during the system upgrade on (b)(6) 2019.Although the exact cause of the reported event cannot be conclusively determined, allergic reaction is a known potential complication with the cangaroo envelope.Instructions for use with the cangaroo envelope state (art 20662b) under the section potential complications: allergic reaction to ecm.
Event or Problem Description
A male patient (age unknown) underwent an upgrade to a biv pacemaker with cangaroo envelope on (b)(6) 2019.The lv lead dislodged and lead revision was performed on (b)(6) 2019.The incision was opened and excessive fluid was noted draining from the pocket, which appeared to be a mixture of blood and a pus-like substance.Cultures were taken of this fluid.Once the fluid was cleared from the pocket, cultures were obtained on a portion of the pouch.Total system extraction (to include biv pacemaker and cangaroo envelope) was on (b)(6) 2019.The patient was re-implanted with a biv icd on (b)(6) 2019 on the right side of the chest (without cangaroo).Nasal screen on (b)(6) 2019 confirmed chronic (b)(6).All lab results/cultures resulted as negative.Patient discharged from hospital on (b)(6) 2019 with doxycycline 14-day treatment (for (b)(6)).Final assessment from the ep team is that the pocket was not infected.However, focus was placed on the purulent exudate and they assume the patient had some type of non-infectious reaction to the pouch utilized during the system upgrade on (b)(6) 2019.

• Brand Name: CANGAROO ENVELOPE
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 8841103
• Report Number: 3005619880-2019-00007
• Device Sequence Number: 11164494
• Product Code: FTM
• UDI-Device Identifier: 00859389005034
• UDI-Public: 01008593890050341721082110M19D1147561
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

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: 08/21/2021
• Device Model Number: CMCV-009-MED
• Device Lot Number: M19D1147561
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention