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

Model Number ENVEOR-L

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

Patient Problem Intimal Dissection (1333)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product was discarded and not returned; therefore, no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn 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 a transcatheter bioprosthetic valve intimal damage occurred at the access site.An intimal repair was performed.It was suspected that the inline sheath of the delivery catheter system (dcs) could have contributed to the event.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the damage was a dissection at the subclavian artery puncture site and surgical vascular repair was performed.Following the repair, decreased blood flow in the left upper limb was observed.The patient was placed under monitoring with conservative treatment.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 9546105
• MDR Text Key: 177147978
• Report Number: 2025587-2020-00024
• Device Sequence Number: 1
• Product Code: NPT
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

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 Model Number: ENVEOR-L
• Device Catalogue Number: ENVEOR-L
• Device Lot Number: 0009846258
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 03/06/2020
• Supplement Dates FDA Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR