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

Model Number D-EVPROP2329US

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Intimal Dissection (1333); Low Blood Pressure/ Hypotension (1914)

Event Date 12/18/2019

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: evolutpro-29-us, serial/lot #: (b)(4), ubd: 24-feb-2021, udi#: (b)(4).Product analysis: the delivery catheter system (dcs) and valve were discarded, therefore no product analysis can be performed.Conclusion: without the return of the products, 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 into a patient with type 0 bicuspid native vale and an aortic root angle of 76 degrees, multiple recaptures were reported due to the challenging anatomy.It was also reported that the implant depth was inadequate, too shallow, therefore multiple recaptures were needed to achieve the proper depth.The valve was ultimately deployed successfully.While removing this delivery catheter system (dcs), and distributing the final dose of contrast under fluoroscopy to check for final valve placement, an aortic dissection was reported.A drop in blood pressure was reported.The patient was urgently transferred to the operating room.The valve was explanted and replaced with a surgical aortic valve, an aortic dissection repair and a coronary artery bypass graft (cabg) were performed.Per the physician, the cause of the aortic dissection was the rub of the dcs along the ascending aorta during the multiple recaptures.It was also reported that the height of the stent frame of the valve caused a larger dissection.Per the physician, both the valve and dcs contributed to the dissection.No additional adverse patient effects were reported.

• Brand Name: EVOLUT PRO PLUS DCS
• 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 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: 9570135
• MDR Text Key: 187050340
• Report Number: 2025587-2020-00103
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000207854
• UDI-Public: 00763000207854
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2020

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: 08/27/2020
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0009896247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/09/2020
• Date Device Manufactured: 08/28/2019
• 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: 80 YR