MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. ECM FOR VASCULAR REPAIR; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number	CMCV-013-609
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No sample is available for evaluation.A review of the complaint log shows that this is the only complaint associated with the reported lot number.Manufacturing review of the device history record for the reported lot shows that all units were quality released on (b)(6) 2018 having met all internal qc acceptance requirements.The exact root cause cannot be conclusively determined.However, it can be noted that the ecm device was placed on a wet lap for approximately 5-7 minutes.The condition of the wet lap and how much solution the ecm device was exposed to while on the wet lap is unknown.
Event or Problem Description
On (b)(6) 2018 it was reported that an ecm for vascular repair device was implanted on a female patient during a common femoral endarterectomy.The ecm was soaked in saline for 1 minute and 24 seconds, then placed on wet lap for approximately 5-7 minutes.After the case was complete, the physician informed the aziyo technical sales representative that while the ecm worked great, a corner of the product had delaminated.The physician stated that he had sewn through all of the ecm layers and put an extra stitch in the corner.The ecm was sutured to the patient's tissue and no adhesive agents were used.The physician also waited extra time to make sure there was no bleeding at the corner of the product.The physician said he was not concerned about the performance of the ecm.According to the physician, the event was not related to the procedure and possibly related to the ecm device.

• Brand Name: ECM FOR VASCULAR REPAIR
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): AZIYO BIOLOGICS, INC.; 1100 old ellis road; ste 1200; roswell GA 30076
• MDR Report Key: 8041697
• Report Number: 3005619880-2018-00011
• Device Sequence Number: 19177383
• Product Code: DXZ
• UDI-Device Identifier: 00859389005140
• UDI-Public: 00859389005140
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: CMCV-013-609
• Device Lot Number: M18K1258
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/06/2018
• 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: Required Intervention