MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION TOOL NU1022 ENSEMBLE DEL SYS 22MM; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number NU1022

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

Medtronic received information that during the implant of this transcatheter pulmonary valve (tpv), during the valve inflation on the ensemble system, the outer balloon ruptured.It is unknown what the pressure was in the balloon at the time of rupture.Because of the rupture, the melody was only partially open, ending in a cylindrical shape.The ensemble could not be retrieved.Surgery was successfully performed to replace the pulmonic artery and valve.No adverse patient effects were reported.The product was discarded and will not be returned.

Manufacturer Narrative

Product analysis: the product was not returned, therefore no product analysis can be performed.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.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.The instructions for use (ifu) indicate the maximum applied pressure for the inner and outer balloons.It was not reported what pressure the balloon was inflated to.(b)(4).

Manufacturer Narrative

The angiograms subsequently were reviewed by the original equipment manufacturer of the delivery system¿s balloon and catheter.Their review concluded that it appeared that the balloon was not fully out of the sheath before the inflation began, which appeared to have constricted the size of the outer balloon at the proximal end.The balloon then burst at the distal end, most likely due to over-inflation (as evidenced by the expulsion of contrast during inflation).Burst pressures are determined by extensive bench testing and the catheters are 100% inspected for burst pressure, and the completed delivery systems are 100% inspected for leaks and pressure.

Manufacturer Narrative

Investigation conclusion: the angiogram review noted that the balloon failure may have been in part due to incomplete unsheathing.It did not appear that specific patient anatomy contributed to the failure.

Manufacturer Narrative

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

• Brand Name: TOOL NU1022 ENSEMBLE DEL SYS 22MM
• 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: 3714918
• MDR Text Key: 16777254
• Report Number: 2025587-2014-00171
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: H080002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: NU1022
• Device Catalogue Number: NU1022
• Device Lot Number: 207478260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2013
• 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: 00028 YR