MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MELODY TRANSCATHER PULMONARY VALVE; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED

Model Number PB1018

Device Problem Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Thrombus (2101); No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned, therefore no product analysis can be performed.Without return of the device, a conclusive cause cannot be determined.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this transcatheter pulmonary bioprosthetic valve (tpbv), into a native mitral valve, the valve was not positioned correctly.Subsequently, seven days later the valve was explanted and a second tpbv was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at (b)(4), both inflow and outflow crowns were bent outwards against the wall.Blue monofilament sutures were attached to the outflow.All leaflets and commissures were intact.No damage noted as received.Thrombus was found seated on each cusp.A broken stent was observed.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The returned device showed thrombus seated on each cusp.A number of factors can affect the creation of thrombus, including medications, peri-procedural injury, and pre-existing patient conditions, and its presence and rate of formation is largely dependent on patient condition.A broken stent was observed which appears to have occurred during explant as surrounding tissue appears to have been cut off and not returned.As the device was modified with the struts bent outwards and device was implanted in the mitral, events appears to be related to the user technique and procedure.The melody device is not designed for the mitral position.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: MELODY TRANSCATHER PULMONARY VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• 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: 7681611
• MDR Text Key: 113769620
• Report Number: 2025587-2018-01729
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00643169588196
• UDI-Public: 00643169588196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2018
• Device Model Number: PB1018
• Device Catalogue Number: PB1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 09/07/2016
• 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: 34 MO
• Patient Weight: 14