MAUDE Adverse Event Report: CRYOLIFE, INC. PULMONARY VALVE & CONDUIT SG; HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT

Model Number SGPV00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 07/24/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the initial report, "on (b)(6) 2020, at [hospital and surgeon name] implanted 2 homografts into the same patient, a (b)(6) year old male.This patient was a lifelong congenital patient of [surgeon name] who only observed this procedure and did not scrub in.I was informed of the patient¿s background by [surgeon] that day during the surgery.Today was the 8th operation for this patient.Previously, the patient received 1 mechanical valve (not on-x), a tissue valve, and 6 cryolife homografts (3 aortic and 3 pulmonary).So on (b)(6) 2 new cryolife homografts were implanted, 1 aortic and 1 pulmonary in a long 12 hour redo surgery.At the end of the case, the echo looked good, and the surgeons were pleased and expressed optimism for a good outcome for this patient.Today, (b)(6) 2020, i attended a ross procedure with [surgeon] for another patient, so he implanted a sgpv00 today.After the surgery was over, he pulled me aside and let me know that the (b)(6) year old patient from (b)(6) died last friday, (b)(6), after a long 12 hour surgery attempt to save his life.He started bleeding, and so they opened his chest, [surgeon] said that the patient had a hole in the aortic homograft in the aorta.So he endeavored to patch the hole, but during that time, perfusion and anesthesia were giving the patient lots of blood fractions, and the patient ended up having complete aorta thrombosis.They tried everything they could, but the patient didn¿t make it.[surgeon] indicated that the patient had some type of autoimmune issue, but didn¿t have the kind of history and knowledge of the patient that [surgeon] has, since this was his congenital patient from infancy.[surgeon] did not indicate that he felt that all this happened because of the cryolife aortic homograft, that there were so many other factors happening that it was a culmination of events, but he found it agreeable and appropriate that i submit a report to be considered.".

Event Description

According to the initial report, "on (b)(6) 2020, at [hospital and surgeon name] implanted 2 homografts into the same patient, a 30 year old male.This patient was a lifelong congenital patient of [surgeon name] who only observed this procedure and did not scrub in.I was informed of the patient¿s background by [surgeon] that day during the surgery.Today was the 8th operation for this patient.Previously, the patient received 1 mechanical valve (not on-x), a tissue valve, and 6 cryolife homografts (3 aortic and 3 pulmonary).So on (b)(6) 2 new cryolife homografts were implanted, 1 aortic and 1 pulmonary in a long 12 hour redo surgery.At the end of the case, the echo looked good, and the surgeons were pleased and expressed optimism for a good outcome for this patient.Today, on (b)(6) 2020, i attended a ross procedure with [surgeon] for another patient, so he implanted a sgpv00 today.After the surgery was over, he pulled me aside and let me know that the 30 year old patient from on (b)(6) died last friday, on (b)(6), after a long 12 hour surgery attempt to save his life.He started bleeding, and so they opened his chest, [surgeon] said that the patient had a hole in the aortic homograft in the aorta.So he endeavored to patch the hole, but during that time, perfusion and anesthesia were giving the patient lots of blood fractions, and the patient ended up having complete aorta thrombosis.They tried everything they could, but the patient didn¿t make it.[surgeon] indicated that the patient had some type of autoimmune issue, but didn¿t have the kind of history and knowledge of the patient that [surgeon] has, since this was his congenital patient from infancy.[surgeon] did not indicate that he felt that all this happened because of the cryolife aortic homograft, that there were so many other factors happening that it was a culmination of events, but he found it agreeable and appropriate that i submit a report to be considered.".

Manufacturer Narrative

No additional information was received.Graft (b)(6) was not returned to cryolife so no direct observations could be made.According to the processing records, this graft did not contain any attributes that would have rejected the graft.According to the information supplied by [surgeon], the patient has undergone life-long treatments to manage his congenital heart disease including, at a minimum, treatment with multiple types of cardiac valves, of which were several cryolife homografts.On (b)(6) 2020, he successfully underwent his 8th operation for this disease with a double-valve replacement.Operative notes are not available, so the indication for the surgery is unknown at this time.On (b)(6) 2020, approximately 2.5 week post-operative, the patient was brought back to the operating room and it was determined he was bleeding from a hole in the conduit of the aortic homograft.Reportedly, the patient experienced a ¿complete aorta thrombosis¿ and did not survive the surgery.[surgeon] indicated there were multiple variables associated with this outcome including a ¿type of autoimmune issue¿.The commentary provided by [surgeon] made no mention complications related to the sgpv homograft.Additionally, the cause of death is unknown at this time as no autopsy report has been provided to date.The cardiac homografts undergo inspection by the dissector as well as by the inspector prior to final packaging.Additionally, the donor was found to be eligible for donation with no history of connective tissue disorder or other disease state which may have weakened the tissue.Immunologic reaction and death are listed as potential adverse event in the cryovalve sg instructions for use and should be considered when selecting the optimal valve replacement for each recipient.All risks identified have been mitigated as far as possible and residual risk is acceptable.There is insufficient information available to determine the relationship of this homograft to the reported events.In the absence of other relevant information, no conclusions can be made regarding what role, if any, the homograft valve may have played in the final outcome for this patient.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.

• Brand Name: PULMONARY VALVE & CONDUIT SG
• Type of Device: HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10454798
• MDR Text Key: 204396793
• Report Number: 1063481-2020-00013
• Device Sequence Number: 1
• Product Code: OHA
• Combination Product (y/n): N
• PMA/PMN Number: K092021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: SGPV00
• Device Catalogue Number: SGPV00
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/29/2020
• Initial Date Manufacturer Received: 07/29/2020
• Initial Date FDA Received: 08/26/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 30 YR