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

Model Number ENVEOR-L

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2017

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the product has not been returned for analysis, therefore no product analysis can be performed.Conclusion: capsule separation typically occurs due to excessive compressive forces applied during the valve loading, tracking, and/or deployment process.This excessive compressive force is typically experienced when the valve is loaded incorrectly.In this case, it was reported that the valve was noticed to have been initially misloaded (curved capsule), but was reportedly straightened out prior to introduction into the patient.It was also reported that a misload was detected upon review of imaging following the procedure.As no fluoroscopic load check images were submitted for review, it cannot be independently determined if the valve was correctly loaded onto the delivery catheter system (dcs).The subject device was not returned for evaluation, but images were provided showing the capsule damage outside of the patient.The lot history review was performed on the device; there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to the implant of a 26 mm transcatheter bioprosthetic valve, it was noted by hospital staff that the capsule was curved at the end of loading.Tension was removed and the capsule no longer appeared curved.No misload was detected at the time and the operators proceeded with the procedure using right femoral artery access.At the beginning of valve deployment, the capsule was noted to be broken.It was reported that there was no unusual tension felt in the system and the capsule did not completely separate.The valve was recaptured and removed from the patient without consequence.A different delivery catheter system was used to successfully complete the procedure.Upon review of angiography by following the procedure, a misload was identified with the delivery catheter system.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

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.The subject device was not returned for evaluation, but images submitted for review also confirm separation of the capsule during deployment.Capsule separation typically occurs due to excessive compressive forces applied during valve loading, tracking, and/or deployment process.This excessive compressive force is typically experienced when the valve is loaded incorrectly.Fluoroscopic images submitted for review confirmed a misloaded valve due to a bent capsule and misaligned paddles.Loading of the valve is a process highly dependent on the operator technique.The device instructions for use (ifu) contains instructions to use the integrated loading bath which features a mirror to aid in accurate placement of the transcatheter aortic valve (tav) frame paddles during loading.The user is instructed to not advance the capsule over the frame paddles unless they are fully seated in the center of the paddle pockets, and to perform an inspection of the loaded capsule under fluoroscopy.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: 7248588
• MDR Text Key: 99245413
• Report Number: 2025587-2018-00322
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2017
• Device Model Number: ENVEOR-L
• Device Catalogue Number: ENVEOR-L
• Device Lot Number: 0008199565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 02/07/2018
• Supplement Dates Manufacturer Received: 02/15/2018; 09/26/2018
• Supplement Dates FDA Received: 02/15/2018; 10/17/2018
• Date Device Manufactured: 08/30/2016
• 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