MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO R DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number ENVEOR-N

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Perforation of Vessels (2135)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device was 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, an attempt was made to access with the delivery catheter system (dcs) via the right access site; however, it was unable to advance through the common iliac artery (cia).The inline sheath was attempted, but did not pass through, therefore an 18 fr non-medtronic sheath was inserted.The valve was successfully implanted.It was reported that the minimum access vessel diameter was 6.6 millimeter (mm) by 7.2 mm.The access route was checked, and a dissection on right cia and perforation from the external iliac artery (eia) were confirmed.Per the physician, the dcs was an unlikely cause of the dissection and perforation; however, it was a possibility as there was difficulty advancing.A 10 millimeter (mm) by 10 centimeter (cm) stent was inserted into the eia and a 10mm by 4cm stent was inserted into the cia.A final angiography confirmed the stent placements were successful and the procedure was completed.It was reported that the procedure time was extended approximately one hour due to the dissection and perforation.It was also reported that the patient had "scattered calcifications", but no severe tortuosity.No additional adverse patient effects were reported.

• Brand Name: ENVEO R DELIVERY SYSTEM
• 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: 9101043
• MDR Text Key: 159452075
• Report Number: 2025587-2019-02886
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2019

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 Model Number: ENVEOR-N
• Device Catalogue Number: ENVEOR-N
• Device Lot Number: 0009460300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 86 YR