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

Model Number T510

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Mitral Regurgitation (1964)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

Citation: kossar ap et al.Direct access valve-in-valve implantation for management of complex valvulopathy.Catheter cardiovasc interv.2019 jun 1;93(7):1385-1388.Doi: 10.1002/ccd.28179.Epub 2019 apr 8.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 a case series describing a technique for elective direct surgical access val ve-in-valve implantation in high-risk patients with severely degenerated aortic or mitral bioprosthetic valves.Case 1: a (b)(6)-year-old female patient who previously underwent surgical aortic valve replacement with a 21 mm non-medtronic bioprosthetic valve presented with bioprosthetic aortic stenosis.Subsequently, the patient underwent aortic valve-in-valve implantation with a 23 mm medtronic evolut r transcatheter valve (serial number not provided).A transesophageal echocardiogram (tee) showed ¿excellent valvular function without leak.¿ at 10 days post implant, it was reported that the patient had a prolonged sinoatrial pause and a permanent pacemaker was implanted.Case 2: an (b)(6)-year-old female patient who previously underwent surgical mitral valve replacement with a 27 mm medtronic hancock ii bioprosthetic valve (serial number not provided) presented with severe mitral regurgitation/insufficiency.Tee exhibited a small left ventricular outflow tract (lvot) and large bioprosthetic struts.Consequently, a direct surgical valve-in-valve implantation technique was performed to avoid potential lvot obstruction.During the procedure, a left atriotomy revealed that the hancock valve had tears in 2 of the 3 leaflets.All 3 leaflets were removed, and a 26 mm non-medtronic transcatheter valve was implanted valve-in-valve.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: 8851655
• MDR Text Key: 152977667
• Report Number: 2025587-2019-02441
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2019

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: T510
• Device Catalogue Number: T510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2019
• Initial Date FDA Received: 08/01/2019
• 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
• Patient Age: 84 YR