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

Model Number ENVEOR-L

Device Problem Insufficient Information (3190)

Patient Problems Intimal Dissection (1333); Fistula (1862); Hematoma (1884); Blood Loss (2597)

Event Date 03/11/2019

Event Type  Injury  

Manufacturer Narrative

Citation: lederman rj et al.The fate of transcaval access tracts: twelve month results of the prospective nhlbi transcaval tavr study.Jacc cardiovasc interv.2019 mar 11; 12(5): 448¿456.Doi: 10.1016/j.Jcin.2018.11.035.Earliest date of publish used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature article regarding the one-year outcomes in patients who underwent transcaval access tract closure with non-medtronic nitinol cardiac occluder devices following transcaval transcatheter aortic valve replacement (tavr).All data were collected from seventeen centers.The study population included 100 patients and was predominantly female with a mean age of 80 years.An unknown number of patients were implanted with medtronic evolut r transcatheter valves.No serial numbers were provided.One evolut r patient died due to a thoracoabdominal aortic dissection caused by the delivery catheter system crossing the aortic arch.Based on the available information, medtronic product was directly associated with the death.An additional 28 deaths occurred within one-year after transcaval tavr.Based on the available information, none of these deaths were attributed to medtronic product.Among all patients, adverse events included: covered stent implantation, iliac dissection requiring inferior vena cava filter placement or conservative treatment, aortic dissection, retroperitoneal hematoma, persistent fistula, major or life-threatening bleeding, blood transfusion, hospital admission for heart failure, and unspecified major adverse cardiovascular events within 30 days after transcaval tavr.Based on the available information, medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• 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: 10268259
• MDR Text Key: 199261149
• Report Number: 2025587-2020-02224
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: ENVEOR-L
• Device Catalogue Number: ENVEOR-L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 80 YR