MAUDE Adverse Event Report: AZIYO BIOLOGICS, INC. PROXICOR FOR CARDIAC TISSUE REPAIR

Model Number CMCV-120-404

Device Problems Break (1069); Peeled/Delaminated (1454); Material Separation (1562)

Patient Problems Death (1802); Aortic Dissection (2491)

Event Date 12/24/2019

Event Type  Death  

Manufacturer Narrative

Manufacturing review of the device history record for the reported lot shows that all units were quality released on 11/27/2019 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during production and final packaging.The oem supplier reviewed the sub-lots associated with the reported lot and confirmed that "all devices met specification." the instructions for use provided with the proxicor for cardiac tissue repair product (art-20700b), under the section 'potential complications', states in part: "the following complications are possible.If any of these conditions occur, a medical professional should evaluate if the removal of the proxicor is required: patch dehiscence or rupture." it can be noted that the reported saline soak time prior to use was 10 minutes.The ifu recommends soak time of 1-2 minutes.The exact cause of the reported event cannot be conclusively determined.

Event Description

On (b)(6) 2019 a newborn female patient underwent surgery for a diagnosis of aortic arch hypoplasia and ivc.Aziyo proxicor for cardiac tissue repair (ctr) was used.Once the patient was sutured, hemodynamic deterioration occured.Arterial line (umbilical artery cannulation) checked; malfunction is ruled out.An ecography checked the position of the ctr patch.Since the hemodynamic compromise was maintained, the patient was reconnected to extracorporeal circulation.Once again exposing the operative field, the doctor visualized that the ctr patch presents what he described as a "dissection" of the same.Ctr removed and replaced with a baxter peri-guard pericardium patch.Patient subsequently taken to neonatal icu where, after a couple of hours, patient expired.

• Brand Name: PROXICOR FOR CARDIAC TISSUE REPAIR
• Type of Device: PROXICOR FOR CARDIAC TISSUE REPAIR
• 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: andrew green ; 1100 old ellis road; ste 1200; roswell, GA 30076
• MDR Report Key: 9664341
• MDR Text Key: 177561445
• Report Number: 3005619880-2020-00001
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K063349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: CMCV-120-404
• Device Lot Number: M19M1538
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 1 MO
• Patient Weight: 2