MAUDE Adverse Event Report: CRYOLIFE, INC. HOMOGRAFT; HEART VALVE, MORE THAN MINIMALLY MANIPULATED ALLOGRAFT

Device Problem Material Puncture/Hole (1504)

Patient Problems Exsanguination (1841); Low Blood Pressure/ Hypotension (1914); Abdominal Distention (2601)

Event Date 05/04/2021

Event Type  Death  

Event Description

Female who is postoperative day 4 following extensive repair of a para visceral mycotic aneurysm with distal descending thoracic to distal abdominal aortic cryopreserved graft through a left thoracotomy and left retroperitoneal approach as well as retrograde de branching of the renal arteries as well as the superior mesenteric artery.She actually tolerated the procedure very well and was making an excellent postoperative recovery.This evening she developed acute arterial hemorrhage emanating from the retroperitoneal drain as well as hypotension and abdominal distention.She was resuscitated in the icu and emergently brought down to the operating room.While resuscitation was ongoing the patient was placed in right lateral decubitus position on a beanbag and prepped and draped in a sterile manner from the level of the shoulder to the knees.Administration of preoperative antibiotic was confirmed, and a procedural pause was quickly observed.The left retroperitoneal incision was quickly opened, and a large volume of arterial blood and clots was evacuated.At this stage the patient became profoundly hypotensive and a fogarty hydragrip clamp was quickly placed on the abdominal segment of the thoracic aorta to abdominal aortic cryopreserved graft.It soon became evident that the bleeding was coming from a significant sized hole that had developed on the anterior wall of the distal aorta aortic cryopreserved graft.There was no hemorrhage from any of the suture lines or any of the other de branching graft.This was repaired with continuous pledgeted 5-0 prolene utilizing bovine pericardium as pledgets given the weak wall of the cryopreserved graft while intermittently cpr was being administered.Findings 1.Large volume arterial blood and clot evacuated from the retroperitoneal wound upon reopening.2.Acute, profuse hemorrhage from 0.75 cm hole anterior wall of distal aspect thoracic to distal abdominal aortic composite cryopreserved bypass graft.This case was substantially more difficult than usual because of significant effort and difficulty mobilizing and identifying anatomical structures due to altered surgical field secondary to previous surgery and tissue friability.This case was substantially more difficult than usual because of prolonged/ significant intra-operative hemorrhage.This case was substantially more difficult than usual because of serious medical condition(s) of the patient.Complications death.

• Brand Name: HOMOGRAFT
• 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: 11791606
• MDR Text Key: 249520222
• Report Number: 11791606
• Device Sequence Number: 1
• Product Code: OHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2021

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 26280 DA