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	Difficult to Insert (1316); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned. 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 or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, using the inline sheath, there was difficulty near the left iliac artery during insertion and the guidewire was exchanged.Resistance was noted while advancing the delivery catheter system (dcs) through both the external and common iliac arteries.After the valve was implanted, as the dcs was being removed from the patient, the nose cone became stuck at the access site.The surgeon used a blade to make space for the nose cone to be removed.An intimal tear was noted in the left femoral artery and was repaired with a graft.The physician reported the tear was likely caused during insertion but was not identified until removal of the dcs at the end of the procedure.It was reported that a non-medtronic closure device was used prior to noting the injury.The minimum femoral access vessel diameter was 5.2 x 7.3mm and the left femoral artery was calcified.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Difficulty advancing or removing the delivery catheter system (dcs) through the access vessel is known to be related to procedural factors, user technique, and/or patient anatomy (angulation, calcification, tortuousity, etc.).The case summary was submitted by the facility showing narrow access vessels (minimum of 5.2mm).This indicates that the potential cause of the difficulty advancing and removing the dcs may have been patient anatomy.Vascular access related complications, such as dissection, are a known potential adverse patient effect per the device instructions for use (ifu), and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).Based on the limited information available, an assignable root cause of the vascular complication cannot be determined and the relationship to the dcs could not be established.If information is provided in the future, a supplemental report will be issued.

• 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: 7594100
• Report Number: 2025587-2018-01452
• Device Sequence Number: 18900759
• Product Code: NPT
• UDI-Device Identifier: 00643169800939
• UDI-Public: 00643169800939
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 11/02/2018

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: 01/03/2019
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008938610
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 11/02/2018
• 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: 89 YR
• Patient Weight: 45