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

Model Number	ENVEOR-N-US
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Product analysis: the product was discarded by the customer; 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 or Problem Description
Medtronic received information that during the attempted implant of a transcatheter bioprosthetic valve, the valve dislodged three times and was recaptured.Upon the fourth deployment attempt, the capsule separated and the valve was unable to be delivered or fully retrieved.It was reported that tension had been felt in the system during deployment due to a tortuous aorta.Due to tortuosity and obesity, a decision was made to perform an arterial cutdown on the left femoral artery to remove the delivery catheter system (dcs) with the partially deployed valve to avoid risk of vessel injury.The physician believed that the cutdown would provide a controlled and safer method for removal.After two hours, due to the patient's size and tortuous anatomy, the valve and dcs were removed from the patient.Patch repair was performed at the left groin.It was decided not to proceed with the implant procedure at that time.It was reported that the procedure was aborted and patch repair completed due to significant damage to the left femoral artery, after the cutdown was performed.No further adverse patient effects were reported.

• Brand Name: ENVEO R DELIVERY SYSTEM
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7031930
• Report Number: 2025587-2017-02131
• Device Sequence Number: 11040087
• Product Code: NPT
• UDI-Device Identifier: 00643169956193
• UDI-Public: 00643169956193
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008653239
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 122