MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 31027

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

Patient Problems Regurgitation (2259); Stenosis (2263)

Event Date 06/03/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Medtronic received information via literature review that a (b)(6) girl with a past medical history of ¿situs inversus and dextrocardia, asplenia, unbalanced complete atrioventricular septal defect with a dominant left ventricle and transposition of the great arteries" was implanted with a medtronic surgical bioprosthetic mitral valve (27-mm, serial number not provided).Six months post-implant, worsening heart failure was noted due to severe regurgitation and mild stenosis.In an intervention a medtronic transcatheter bioprosthetic valve was successfully implanted valve-in-valve.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC PORCINE 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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5305187
• MDR Text Key: 33701736
• Report Number: 2025587-2015-01333
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990064
• 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,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31027
• Device Catalogue Number: 31027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 00039 MO