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

Model Number ENVPRO-16-US

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the delivery catheter system (dcs) was not returned, therefore no product analysis can be performed.Conclusion: without 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, the delivery catheter system (dcs) at tempted to cross through a tortuous iliac artery over a non-medtronic guidewire.Force was applied but the dcs would not pass.When pushing attempts were made, the outflow portion of the capsule appeared bent.The system was removed.Upon removal from the patient, the dcs was inspected and due to the force applied, a crack in the outflow portion of the capsule was observed.It was reported that a small area of separation was noted and when the technologist bent the capsule to inspect it, the capsule became completely separated.A different dcs and different valve were used with a different non-medtronic guidewire.The new system passed through the anatomy without incident.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received with the valve loaded in the capsule.The valve could not be removed from the dcs.The dcs was received with the handle and tip-retrieval mechanism intact, the capsule partially opened, and the end cap/screw gear snap fit connected.The deployment knob retracted and advanced the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.Delamination was observed over the nitinol reinforcing frame along the proximal, distal, and mid-section of the capsule.Damage was observed on the polymer material surface along the distal side of the capsule.There was a break observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.The capsule was bent at the separation site.The separation site was observed to be jagged and uneven.The reported event for unable to advance and capsule separation could be confirmed in the analysis.Conclusion: the subject dcs was returned for analysis.Delamination was observed on the capsule, which typically occurs when the capsule is subjected to a bending force, potentially after tracking through tortuous anatomy.The device was received with the capsule separated, confirming the reported event.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 device instructions for use (ifu) instructs: if there is a significant increase in resistance, stop advancement and investigate the cause of the resistance (for example, magnify the area of resistance) before proceeding.Do not force passage.Forcing passage could increase the risk of vascular complications (for example, vessel dissection or rupture).Difficulties advancing the dcs is known to be related to procedural factors, user technique, and/or patient anatomy (angulation, cal cification, tortuousity, etc.).In this case, it was reported that the patient presented with a tortuous iliac artery.This indicates the probable cause of the advancement issues was patient anatomy.However, with the limited information available, the cause of the difficulty advancing the dcs could not be determined and a relationship to the dcs cannot be established.There is no information to suggest a device malfunction or a failure to meet manufacturing specifications.Capsule separation occurs due to excessive compressive forces applied to the capsule.Forces in the system is a cumulative effect that may be increased by factors such as tortuous anatomy and load quality.No procedural images or fluoroscopic load check images were submitted for review.In this case, the root cause of the capsule separation could not be determined and a relationship to the dcs cannot be established.Updated: d9, h3, h6 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: ENVEO PRO DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 12240819
• MDR Text Key: 264066517
• Report Number: 2025587-2021-02384
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00643169987210
• UDI-Public: 00643169987210
• 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: 08/23/2021

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: 11/02/2022
• Device Model Number: ENVPRO-16-US
• Device Catalogue Number: ENVPRO-16-US
• Device Lot Number: 0010438363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 08/16/2021
• Supplement Dates FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR