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

Model Number	CMCV-072-606
Medical Device Problem Code	Delamination (2904)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review of the aziyo device history record for the reported lot shows that all units were quality released on 11/29/16 having met all internal qc acceptance requirements.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.There were no non-conformances associated with the manufacturing lot.A dhr review of lb937920 was requested and received from the ecm supplier that showed visual non-conformances with the sublots.The sublots were dispositioned according to manufacturing procedure.The ecm supplier results summary states that, "based upon the review results, the non-conformances had no impact on the reported issue".Used and unused product samples were returned for investigation both samples were shown to have some degree of delamination.If the used sample was the sample that the facility was referring to in the event description, the ifu states that the ecm should be soaked in a bowl of sterile saline or other sterile isotonic solution for approximately 1-2 minutes prior to use (use at least 50 ml).It was stated that the ecm was not hydrated in any solution and only the patients' blood was used.This is not appropriate preparation of the ecm according to the ifu.The ifu states that if delamination is observed to not use the ecm device.According to the cormatrix ecm for carotid repair instructions for use (ifu) (20463-062014) that was provided in this lot, it states under indications for use, "the cormatrix ecm for carotid repair is indicated for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture-line buttressing." the repair location was stated generically as "aortic repair".Under the section 'warnings and precautions' it states, "ensure that the device is hydrated prior to suturing.Without proper hydration, the ecm may tear and not retain sutures.Additionally, excessive hydration may result in delamination.If delamination is observed, do not use the cormatrix ecm." under the section labeled suggested instructions for using the cormatrix ecm' is states, "3.Hydrate the cormatrix ecm by placing it in a bowl of sterile saline or other sterile isotonic solution for approximately 1-2 minutes prior to use.Use at least 50 ml of the sterile solution for hydration.It is recommended that the ecm not be excessively handled or manipulated prior to use.5.If required, the cormatrix ecm can be cut to the appropriate size, using aseptic technique in order to adequately cover the tissue deficiency/defect or treatment area.If delamination is observed, do not implant the cormatrix ecm." the exact root cause of the reported delamination cannot be conclusively determined.
Event or Problem Description
It was reported that after opening the box and sterile package it was observed that the ecm was delaminated.Another one was opened and used without further issues.Additional information was requested on 8/8/2017.Additional information received on 9/14/2017 that states, "on (b)(6) 2017 an aortic repair was completed on a (b)(6) male.The ecm was not hydrated in any solution and only the patients' blood was used.During suturing of the patch delamination was observed.The ecm was removed and the patch was changed." it was stated that the surgical time was prolonged (but did not state significantly).The final outcome of the patient was good with no complications.

• Brand Name: CORMATRIX ECM FOR CAROTID 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: 6941250
• Report Number: 3005619880-2017-00031
• Device Sequence Number: 873033
• Product Code: DXZ
• UDI-Device Identifier: 00859389005089
• UDI-Public: 00859389005089
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K111187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2017

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: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: CMCV-072-606
• Device Lot Number: M16M1303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 10/11/2017
• 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
• Patient Age: 3 MO