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

Model Number T505

Device Problems Material Perforation (2205); Material Deformation (2976); Unintended Movement (3026); Separation Problem (4043)

Patient Problems Host-Tissue Reaction (1297); Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Endocarditis (1834); Thrombus (2101); Blood Loss (2597)

Event Date 01/01/2007

Event Type  Injury  

Manufacturer Narrative

Citation: butany et al.A 10-year comparison of explanted hancock-ii and carpentier-edwards supraannular bioprostheses.Cardiovascular pathology, 2007 jan-feb; 16(1): 4-13.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 a 10-year comparison of explanted hancock-ii and carpentier-edwards supra-annular bioprostheses.All data were collected from bioprostheses explanted from a single center between january 1994 and june 2004.The overall implant population included 2839 patients, 2297 patients (predominantly male, mean age 62.8 years) of which were implanted with medtronic hancock ii bioprosthetic valves (no serial numbers provided) designed for atrial or mitral valve positions.From january 1994 and june 2004, a total of 163 valves (98 hancock ii and 65 carpentier-edwards) were explanted and analyzed in this study.Observations of explanted hancock ii valves included evidence of: outward splaying of the stent posts, material dehiscence/detachment, calcification, tear/perforation, cusp prolapse, pannus, thrombus, endocarditis, hemorrhage, lipid/serum insudation, stenosis, and incompetence.Based on the available information medtronic product was directly associated with the observations.No additional adverse patient effects or product performance issues 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: 9124751
• MDR Text Key: 160235844
• Report Number: 2025587-2019-02929
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 09/11/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR