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

Model Number T505

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aortic Regurgitation (1716)

Event Date 11/01/2011

Event Type  Injury  

Manufacturer Narrative

Citation: bedogni et al.Transcatheter valve-in-valve implantation using corevalve revalving system for failed surgical aortic bioprostheses.Jacc cardiovasc interv.2011 nov;4(11):1228-34.Doi: 10.1016/j.Jcin.2011.10.002.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 the performance of transcatheter valve-in-valve implantation in patients with a degenerated aortic bioprosthetic valve.All data were collected from multiple centers prior to 2011.The study population included 25 patients (mean age 82.4 years) with a stenotic or regurgitant bioprosthetic valve.Four patients had previously implanted medtronic mosaic (3) or hancock (1) bioprosthetic valves.All patients were implanted with a medtronic corevalve (25).No serial numbers were provided.Among the four medtronic surgical valve patients, all valves were noted with aortic regurgitation which required intervention.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: 8174005
• MDR Text Key: 130654530
• Report Number: 2025587-2018-03451
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• 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: 12/13/2018
• 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: 82 YR