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

Model Number T505

Device Problems Structural Problem (2506); Insufficient Information (3190)

Patient Problems Aneurysm (1708); Stroke/CVA (1770); Endocarditis (1834); Regurgitation (2259); Blood Loss (2597); Thromboembolism (2654); Vascular Dissection (3160)

Event Date 01/01/2006

Event Type  Injury  

Manufacturer Narrative

Citation: borger et al.Twenty-year results of the hancock ii bioprosthesis.J heart valve dis.2006 jan;15(1):49-55.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.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding 20-year results of hancock ii porcine bioprosthetic valve in a large patient population.All data were collected by mail and/or telephone questionnaire for patients who underwent surgery between 1982 and 2001.The study population included 1,569 patients (predominantly male, mean age 67 years), all of which were implanted with medtronic hancock ii porcine bioprosthetic valve in the atrial (1,010) or mitral (559) position.No serial numbers provided.Among all patients, adverse events included: thromboembolism/stroke/transient ischemic attack, endocarditis, major bleeding, structural valve dysfunction (svd), aneurysm/dissection, paravalvular leak, and valve-related reoperation.Based on the available information medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• Brand Name: HANCOCK II 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: 8493306
• MDR Text Key: 141307717
• Report Number: 2025587-2019-01158
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980043
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• 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
• Date Manufacturer Received: 04/01/2019
• 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): Life Threatening; Required Intervention
• Patient Age: 67 YR