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

Model Number T510

Device Problem Occlusion Within Device (1423)

Patient Problems Mitral Regurgitation (1964); Mitral Valve Stenosis (1965)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

Citation: lelek m.Transcatheter transapical valve-in-valve implantation for degenerated mitral bioprosthesis.Postepy kardiol interwencyjnej.2017;13(4):345-346.Doi:10.5114/aic.2017.71621.Epub 2017 nov 29.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.

Event Description

Medtronic received information via literature regarding (b)(6) woman with a history of coronary artery bypass grafting (cabg), arterial hypertension, diabetes, stroke who had been implanted with mosaic 19 mm valve in aortic position and hancock ii 25 mm bioprosthesis in mitral position.A mitral transcatheter valve in- valve was implanted (tviv) due to degenerated bioprosthesis in the mitral position with severe eccentric regurgitation.No additional adverse patient effects or product performance issues were reported.

• Brand Name: HANCOCK II 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: 7262021
• MDR Text Key: 99765638
• Report Number: 2025587-2018-00346
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: Health Professional
• Type of Report: Initial
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T510
• Device Catalogue Number: T510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• 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: 76 YR