MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number EVOLUTPRO-26-US

Device Problems Perivalvular Leak (1457); Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problems Intimal Dissection (1333); Cardiac Arrest (1762); Death (1802)

Event Date 08/14/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: product id: ev olutpro-26-us, serial/lot #: (b)(4), ubd: 02-jun-2021, udi#: (b)(4).Product analysis: the valves were discarded, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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 bioprosthetic valve, the first valve dislodged and a second transcatheter bioprosthetic valve was implanted.The second valve did not help and the patient crashed while on the pump.The valves were removed and replaced with a surgical aortic valve replacement (avr).No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information was received that following the second valve implant, moderate pvl was reported.The fissure may have been caused by the original balloon dilatation or the valve dislodging.The fissure was the fused leaflet of the bicuspid native valve.The patient died seven days post valve implant.The document cause of death is unknown and it is unknown if an autopsy was performed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received that the first valve was implanted at a depth of 6 mm on the non-coronary cusp (ncc) and 6 mm on the left coronary cusp (lcc) when deployment was initiated.When the crowns came out, but the paddles were still attached, the valve moved up to 0-0mm.When the paddles were released, the valve dislodged into the ascending aorta.Per the physician, the reason the patient crashed and went into asystole, requiring cardiopulmonary resuscitation (cpr), was due to wide open paravalvular leak (pvl) that was present following the first valve dislodgement.The patient did not tolerate the pvl and the second valve did not resolve the pvl and the valve was constrained.A possible fissure created in the bicuspid valve that could not be resealed by the second valve.It was reported that the patient was in a medically induced coma.It was reported that the patient died thirteen days post valve implant.The cause of death is unknown.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVOLUT PRO TRANSCATHETER 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
• MDR Report Key: 8915030
• MDR Text Key: 155026058
• Report Number: 2025587-2019-02617
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000017828
• UDI-Public: 00763000017828
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/05/2019

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 Expiration Date: 06/02/2021
• Device Model Number: EVOLUTPRO-26-US
• Device Catalogue Number: EVOLUTPRO-26-US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 08/21/2019
• Supplement Dates Manufacturer Received: 08/14/2019; 08/29/2019
• Supplement Dates FDA Received: 08/29/2019; 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 76 YR