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

Model Number 242

Device Problems Calcified (1077); Material Separation (1562); Material Split, Cut or Torn (4008)

Patient Problems Host-Tissue Reaction (1297); Calcium Deposits/Calcification (1758); Congestive Heart Failure (1783); Endocarditis (1834); Insufficiency, Valvular (1926); Mitral Regurgitation (1964); Cardiogenic Shock (2262); Thromboembolism (2654)

Event Date 10/01/2004

Event Type  Injury  

Manufacturer Narrative

Citation: doenst et al.Long-term results of bioprosthetic mitral valve replacement: the pericardial perspective.J cardiovasc surg (torino).2004 oct;45(5):449-54.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.[(b)(4)].

Event Description

Medtronic received information via literature regarding long-term results of bioprosthetic mitral vale replacements.All data were collected from a meta-analysis review of articles published between 1972 and 2003.The study population included an unspecified number of patients (no demographics provided), in which medtronic hancock standard bioprosthetic valves were implanted (no serial numbers provided).Among hancock standard valves, adverse events included: severe acute mitral regurgitation (mr), symptoms of heart failure, cardiogenic shock, and surgical intervention related to structural valve dysfunction (svd) in the form of cuspal tears.The authors stated cuspal tears were more likely to occur in the mitral than the aortic position due to the increased mechanical stress due to higher closing pressures.Among all manufacturer¿s valves, other adverse events included: host tissue overgrowth, calcification, thromboembolism, endocarditis, valve dehiscence, and paravalvular leak (pvl).Based on the available information medtronic product may have been associated with these adverse event(s).No additional adverse patient effects or product performance issues were reported.

• Brand Name: HANCOCK 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: 9136789
• MDR Text Key: 166217648
• Report Number: 2025587-2019-02965
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 242
• Device Catalogue Number: 242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2019
• 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): Required Intervention