MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T505

Device Problems Gradient Increase (1270); Occlusion Within Device (1423)

Patient Problems Aortic Valve Stenosis (1717); Low Blood Pressure/ Hypotension (1914); Thrombus (2101)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

Citation: fan j.A rare case report of early bioprosthetic valve thrombosis presenting with acute heart failure salvaged by thrombectomy.J cardiothorac surg.(b)(6) 2017;12(1):19.Doi: 10.1186/s13019-017-0581-9.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding (b)(6) male with congenital bicuspid aortic valve had been implanted with 21 mm hancock ii porcine valve.The serial number was not provided.At 11-months post-implant, the patient became hemodynamically unstable due to aortic valve stenosis secondary to thrombus formation in the aortic valve.An increased mean transvalvular gradient of 58 mmhg with a restricted valve opening was noted.A surgical exploration was performed showing thrombus adhered to the aortic side with diffuse valvular thickening.A thrombectomy was performed.No additional adverse patient effects or product performance problems were reported.

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
• 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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7203611
• MDR Text Key: 97672878
• Report Number: 2025587-2018-00203
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P790007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2018
• Initial Date FDA Received: 01/18/2018
• 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): Required Intervention
• Patient Age: 61 YR