MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number D-EVPROP2329US

Device Problems Material Separation (1562); Failure to Advance (2524); Difficult to Advance (2920)

Patient Problems Intimal Dissection (1333); Calcium Deposits/Calcification (1758); Death (1802); Aortic Dissection (2491)

Event Date 07/07/2020

Event Type  Death  

Manufacturer Narrative

Product analysis: the delivery catheter system (dcs) was discarded, therefore no product analysis can be performed.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 Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve via right femoral access, the delivery catheter system (dcs) was unable to pass the bifurcation at the common iliac artery (cia) due to calcification.Multiple attempts were made, but were unsuccessful.The dcs was withdrawn and an 18 french sheath was inserted.Upon inspection of the dcs, the capsule was torn and the polymer coating had been scuffed by the calcium.A new valve and a new dcs were used to complete the procedure.It was reported that a dissection occurred in the common iliac artery due to excessive calcification.Subsequently, two stents were placed to repair the injury.Per the physician, the dissection was attributed to excessive calcium.It was also reported that it was possible that the dcs or introducer sheath caused or contributed to the dissection.The patient died due to an aortic dissection.It is unknown if an autopsy was performed.

Manufacturer Narrative

Updated data: the first medwatch (2025587-2020-02244) was submitted on the incorrect delivery catheter system (dcs).The lot number of the delivery catheter system (dcs) has been updated on this report in section d.The first delivery catheter system (dcs) was unable to be advanced past the iliac artery.Once removed from the patient, the polymer of the capsule was noted to be scraped and was not separated as was previously reported.No other complaints were made against the delivery catheter system (dcs).H.2.6 patient and device codes have been updated.H10: additional information indicated that the second delivery catheter system (dcs) was able to be advanced through the iliac artery and into the annulus but force was required to pass through the iliac bifurcation and the aortic arch.It was noted that the patient had excessive calcification throughout the access route.After the valve was implanted a dissection at the aortic arch and at the right iliac artery were noted.Cardiopulmonary resuscitation (cpr) was initiated, however the patient died.It was reported that the dissections were possibly caused by the dcs as force was required to advance the dcs through the vessel.It was also reported that the anatomy was extremely calcified, and the patient had significant heart failure and had no other feasible access routes.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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: EVOLUT PRO PLUS DCS
• 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: 10283816
• MDR Text Key: 199103481
• Report Number: 2025587-2020-02244
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000207854
• UDI-Public: 00763000207854
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0010157419
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 07/16/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR