MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number UNKNOWN

Device Problem Material Rupture (1546)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Endocarditis (1834); Pseudoaneurysm (2605)

Event Type  Death  

Event Description

Medtronic received information that a retrospective study was performed to evaluate reoperations on patients previously implanted with stentless aortic bioprosthetic valves at one center between 1993 and 2005.The study population included 57 patients (predominantly male; mean age of 63.1 years), ten of which were previously implanted with medtronic valves.Across all patients, a total of six perioperative deaths occurred.Four of the six deaths were associated with medtronic products.Patient 1 presented with endocarditis and a large perivalvular abscess three months post-implant of medtronic bioprosthetic valve.The reoperation included homograft aortic root replacement, tricuspid valve repair and resection, and saphenous vein reconstruction of the left main as well as the proximal left anterior descending, circumflex, and right coronary arteries.The patient was taken to the intensive care unit in stable condition, but then had a sudden cardiac arrest and could not be resuscitated despite emergency bypass of the distal left anterior descending and obtuse marginal arteries.Patient 2 presented with endocarditis with a large abscess and false aneurysm four months post-implant of medtronic bioprosthetic valve.The patient had extreme pericardial adhesions and refractory ventricular fibrillation developed during exposure of the heart.Emergency cardiopulmonary bypass (cpb) through the femoral vessels was followed by homograft aortic root replacement with resection and reconstruction of the intervalvular body, saphenous vein reconstruction of the proximal right coronary artery, and pericardial patch repair of the right pulmonary artery.The patient could not be weaned from cpb and died intraoperatively.Patient 3 had structural valve dysfunction nine post-implant of medtronic bioprosthetic valve.The entire valve was completely calcified and adherent to the aortic root, which necessitated complete root resection and anastomosis of a dacron graft to the left ventricular outflow tract.A mechanical valve was implanted in the dacron graft 6 mm above the proximal suture line, the coronary buttons were re-anastomosed after interposition grafting of the proximal right coronary artery, and a single bypass graft was performed to the distal posterior descending artery.The patient initially did very well, but died four days postoperatively from massive pulmonary embolism.Patient 5 had aortic insufficiency secondary to a torn leaflet seven years post-implant of medtronic bioprosthetic valve.The leaflets of the freestyle valve were removed, and an autologous pericardial patch was used to enlarge the non-coronary sinus and annulus.A size 21 stented bioprosthesis was inserted uneventfully, however after arriving in the intensive care unit the patient had a sudden cardiac arrest and could not be.Autopsy revealed fresh antemortem thrombus on the stented bioprosthesis with emboli down both coronary systems.The cause for the thrombus was never determined.No additional adverse patient effects associated with medtronic products were reported.

Manufacturer Narrative

Dates of deaths unknown.The devices were not returned to medtronic.(b)(4).Title: stentless aortic valve reoperations: a surgical challenge authors: michael a.Borger, md, phd, kriengchai prasongsukarn, md, susan armstrong, ms, christopher m.Feindel, md, and tirone e.David, md journal: annal of thoracic surgery 2007;84:737¿ 44).

Manufacturer Narrative

Requests for additional information provided no further details.Conclusion: no devices were returned, and no unique device identifier numbers were provided.Without this information a review of the device history record could not be performed and root cause could not be identified.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4772490
• MDR Text Key: 5781464
• Report Number: 2025587-2015-00548
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2015

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: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2015
• Initial Date FDA Received: 05/14/2015
• Supplement Dates Manufacturer Received: Not provided; 05/29/2015
• Supplement Dates FDA Received: 06/22/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization; Required Intervention
• Patient Age: 00063 YR