MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION COREVALVE 29MM AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number MCS-P3-29-AOA-US

Device Problems Separation Failure (2547); Malposition of Device (2616); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2015

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve dislodged from the annulus after multiple attempts were made to release the delivery catheter system (dcs) from the valve¿s second frame loop.After the specified manipulation to release the tabs, as the valve was being pulled back with one frame loop still attached the dcs, the valve released and was left implanted in the ascending aorta.A snare was used to hold the first valve in place while a second transcatheter bioprosthetic valve was successfully implanted.No adverse patient effects were reported.

Manufacturer Narrative

The device remains implanted, therefore no product analysis can be performed.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

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 subject device and the cine angiogram were not provided for evaluation.It is possible that this event is related to user technique and patient anatomical factors, but an assignable root cause cannot be determined at this time.The ifu instructs the user as follows: "use orthogonal views under fluoroscopy to confirm that the frame loops have detached from the catheter tabs.If a frame loop is still attached to a catheter tab, do not pull on the catheter.Under fluoroscopy, advance the catheter slightly and, if necessary, gently rotate the handle clockwise (<(><<)>180°) and then counterclockwise (<(><<)>180°) to disengage the loop from the catheter tab.".

Manufacturer Narrative

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

• Brand Name: COREVALVE 29MM AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• 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: 4964216
• MDR Text Key: 22025196
• Report Number: 2025587-2015-00816
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2017
• Device Model Number: MCS-P3-29-AOA-US
• Device Catalogue Number: MCS-P3-29-AOA-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2015
• 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: 00073 YR