MAUDE Adverse Event Report: CRYOLIFE, INC. CRYOPATCH SG PULMONARY TRUNK PATCH; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number SGP010

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Congenital Defect/Deformity (1782); Not Applicable (3189)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the implant summary card received, previously implanted cryolife tissue was explanted on (b)(6) 2018.

Manufacturer Narrative

According to the implant summary card received, previously implanted cryolife tissue was explanted on (b)(6) 2018.According to internal records, no previous allograft was found for the patient.Multiple attempts have been made to obtain additional information from cryolife rep, the facility and the operating surgeon.All attempts have gone unmet.No additional information is available.As there is no alleged deficiency being made against the synergraft pulmonary trunk patch this event will not be investigated any further.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

According to the implant summary card received, previously implanted cryolife tissue was explanted on (b)(6) 2018.According to internal records, no previous allograft was found for the patient.

• Brand Name: CRYOPATCH SG PULMONARY TRUNK PATCH
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 8077723
• MDR Text Key: 127369556
• Report Number: 1063481-2018-00046
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K101866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SGP010
• Device Catalogue Number: SGP010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR