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

Model Number 342

Device Problem Calcified (1077)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Heart Failure (2206); Low Cardiac Output (2501); Blood Loss (2597)

Event Date 09/01/1986

Event Type  Death  

Manufacturer Narrative

Citation: kagawa y.Intermediate term results of isolated mitral valve replacement with glutaraldehyde-preserved porcine xenograft valve: clinical and hemodynamic comparison between hancock valve and angell-shiley valve.Tohoku j exp med.1986 sep;150(1):37-50.Doi: 10.1620/tjem.150.37 earliest date of publish used for event date and death 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 comparing the clinical and hemodynamic results of two porcine bioprosthetic valves used for isolated mitral valve replacement (mvr).All data were collected from a single center between 1976 and 1980.The study population included 30 patients (predominantly male, mean age 35 years), 23 of which were implanted with medtronic hancock bioprostheses (no serial numbers provided).Among all patients, deaths occurred due to: structural valve dysfunction caused by calcification, heart failure resulted from prosthesis structural valve dysfunction, severe low cardiac output syndrome from structural valve dysfunction, and bleeding related to anticoagulation therapy.No further details were provided on these deaths.Multiple manufacturers were noted in the literature.Based on the available information medtronic product may have been associated with the deaths.Among all patients, adverse events included: structural valve dysfunction, calcification, stenosis, stiffening, rupture, cerebral em bolisms, bleeding, thromboembolism and elevated trans-mitral valve gradients.Based on the available information medtronic product was directly associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: HANCOCK MITRAL 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: 9269073
• MDR Text Key: 164793515
• Report Number: 2025587-2019-03364
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P870078
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 342
• Device Catalogue Number: 342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2019
• 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): Death; Life Threatening; Required Intervention
• Patient Age: 35 YR