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	Perivalvular Leak (1457); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Heart Failure (2206); Cardiac Tamponade (2226); Vascular Dissection (3160); Pericardial Effusion (3271)
Date of Event	04/25/2017
Type of Reportable Event	Death
Additional 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.The main component of the system.Other relevant device are: product id: evolutr-34-us, serial (b)(4), use by date 2019-03-07, (b)(4).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 or Problem Description
Medtronic received information that during the implant of a transcatheter bioprosthetic valve, the valve was implanted at an optimal depth of 3 mm on the non-coronary cusp (ncc) and left coronary cusp (lcc).A transesophageal echocardiogram (tee) showed mild¿moderate paravalvular leak (pvl).It was decided to perform a post-implant balloon aortic valvuloplasty (bav) with a 28 mm non-medtronic balloon.The distal marker of the balloon was placed approximately 1-2 mm below the inflow tract of the valve and the patient was paced at 180 beats per minute (bpm) while the balloon was inflated.While deflating the balloon, pacing was turned off.When starting to pull the balloon out from the valve, it was noted that the balloon was not completely deflated and the valve subsequently dislodged.After the balloon was removed from the valve and pulled into the descending aorta, the valve was noted to be sitting in the ascending aorta, just below the ostium of the innominate artery.A second transcatheter bioprosthetic valve was loaded and inserted into the patient using transfemoral access on the left side.The valve tracked well through the anatomy but then had difficulty passing through the first valve in the ascending aorta.As the second valve passed through the first valve, it dragged the first valve down to the top of the sinotubular junction.It was reported that the physicians wanted the first valve to sit higher in the ascending a orta where it was prior to passing the second valve through, therefore a decision was made to pull this delivery catheter system (dcs) back through the first valve to place it higher in the ascending aorta.The attempt was successful, but once again the first valve needed to be crossed.After several attempts, the first valve was crossed and it stayed in position.However, angiography showed an aortic dissection on the inner curve of the aortic arch and an annular dissection was noted on the non-coronary cusp.With the patient becoming hypotensive, it was decided to quickly deploy the second valve and determine the treatment options.The second valve was deployed at an optimal depth of 4 mm on the ncc and lcc.Despite the optimal deployment of the second valve and medicinal treatment from anesthesia, the patient was not responding and continuing to become more hypotensive.An echocardiogram showed a pericardial effusion and tamponade.A pericardiocentesis was performed to drain the fluid.Despite the drain, the patient continued to decompensate.Defibrillation and chest compressions were performed.The patient was still unresponsive and in complete heart failure.The decision was made by the physicians to discontinue treatment after it was felt they had exhausted all options.The patient subsequently expired during the procedure.It is unknown whether an autopsy was performed.
Additional Manufacturer Narrative
Additional information was received that both the right and left iliofemoral vessels were aneurysmal and tortuous from the external iliacs into the abdominal aorta bilaterally.The physician reported that the dissections were likely caused by the movement of the first valve that was dislodged which moved up and down in the ascending aorta.
Additional Manufacturer Narrative
Corrected information: no eval explain code.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.

• 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: 6575187
• Report Number: 2025587-2017-00818
• Device Sequence Number: 628528
• Product Code: NPT
• UDI-Device Identifier: 00643169640337
• UDI-Public: 00643169640337
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 05/18/2017

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: 01/27/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008473148
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: Not provided; 05/18/2017
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 05/19/2017; 09/07/2017
• 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: Death
• Patient Age: 86 YR