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

Model Number T505

Device Problems Gradient Increase (1270); Occlusion Within Device (1423)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717)

Event Date 02/21/2017

Event Type  Injury  

Manufacturer Narrative

Citation: castriota f.Transcatheter aortic valve-in-valve implantation using lotus valve for failed surgical bioprostheses.Ann thorac surg.2017 aug;104(2):638-644.Doi: 10.1016/j.Athoracsur.2016.11.020.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding transcatheter aortic valve-in-valve implantation using lotus valve for failed surgical bioprostheses.All data were collected from multiple centers.The study population included 12 patients (mean age 71 years) of which a (b)(6) year-old patient was implanted with a 25 mm hancock bioprosthetic valve.The serial number was not provided.Four-year post implant, a valve-in-valve procedure was performed due to increased gradient, regurgitation and stenosis.No additional adverse patient effects or product performance problems 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: 7231013
• MDR Text Key: 98673208
• Report Number: 2025587-2018-00259
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 01/31/2018
• 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: 75 YR