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

Model Number ENVEOR-N-C

Device Problems Kinked (1339); Failure to Advance (2524)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

The product was not returned, therefore no product analysis can be performed.Without return of the product, a conclusive cause cannot be determined.Other relevant device(s) are: product id: gwbc30, lot unknown.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this 34-millimeter (mm) transcatheter bioprosthetic valve, the delivery catheter system (dcs) was attempted to be inserted into the tissue tract, but the dcs would not advance.The dcs was pushed into and thru the tissue tract, to the point where the guidewire was kinked inside the tissue tract or right femoral artery (rfa).The dcs was removed and serial dilators of 12 fr, 16 fr and 20 fr were inserted into the right peripheral artery via the rfa.Hemodynamic instability then occurred with a drop-in blood pressure.A vascular access site hemorrhage was noted.A vascular surgeon then performed a cutdown to the rfa and a vascular complication of an unknown type was then visually observed.With the vascular injury repaired, flow was then restored with an excellent pulse.No further adverse patient effects were reported.

Manufacturer Narrative

Additional information reported that no issues with the guidewire were noted and the guidewire was discarded per their hospital policy.The guidewire was not reshaped and no bends, kinks, coil separations or other damage was observed prior to insertion.The guidewire was introduced into the ventricle through a catheter that was already positioned in the ventricle.The guidewire was not torqued or twisted, and no resistance was felt during insertion.The physician felt that no malfunction of the guidewire caused this event.No further 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
• 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: 6976791
• MDR Text Key: 90225072
• Report Number: 2025587-2017-01914
• Device Sequence Number: 1
• Product Code: NPT
• 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,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2018
• Device Model Number: ENVEOR-N-C
• Device Catalogue Number: ENVEOR-N-C
• Device Lot Number: 0008613322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2017
• Date Device Manufactured: 05/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 130