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

Model Number D-EVPROP2329US

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

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

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: no product was returned.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 this transcatheter bioprosthetic valve, the valve dislodged.A second deli very catheter system (dcs) and second valve were attempted.However, the dcs could not advance through the first valve and the dcs manipulation caused the catheter to buckle.This second system was removed from the patient.After snaring the initial valve, a third system successfully implanted an additional valve.No adverse patient effects were reported.

Manufacturer Narrative

Additional information was received that the patient anatomy consisted of an aortic root angle of 61 degrees with protruding annular calcification and tortuous right and left ilio femoral arteries.The minimum diameter of the access vessel was noted to be 7.5 millimeter (mm).There was no difficulty with delivery catheter system (dcs) insertion.No adverse patient effects were reported.Updated data: d1, d4, h4 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.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.

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 delivery catheter system (dcs) was returned for analysis.Damage is observed on the polymer material surface along the mid-section of the capsule which is consistent with the reported tracking difficulties.The reported event for buckle could not be confirmed in the analysis, the capsule did not appear to be buckled.Images were submitted to medtronic for review.The image review showed no valve load checks for this event.The imaging provided confirms on a post balloon aortic valvuloplasty (bav) the valve dislodged above the annulus.A snare was used to secure the first valve system.The second system will not advance through the first valve system and is getting hung up at the outflow of the first valve system.There is no additional imaging confirming a third system was used as stated in this event report.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 anatomy consisted of an aortic root angle of 61 degrees with protruding annular calcification and tortuous right and left ilio femoral arteries.This indicates the probable cause of the advancement issues was patient anatomy.However, without procedural images and limited evidence available, an assignable root cause could not be determined and a relationship to the dcs cannot be established.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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the subject delivery catheter system (dcs) was received with the handle intact.The device was received with the capsule partially opened.The deployment knob retracted and advanced the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism was intact.The device was returned with the end cap/screw gear snap fit connected.Damage is observed on the polymer material surface along the mid-section of the capsule.The inner member shaft and spindle hub appeared intact with no evidence of damage.The distal side of the middle member does not appear to be straight.The outer shaft was noted to be bent along the distal section, close to the distal side of the capsule.Conclusion: the investigation is in progress.Updated h6 - eval method, eval results, eval conclusion codes.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 DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 12094872
• MDR Text Key: 262632624
• Report Number: 2025587-2021-02042
• Device Sequence Number: 1
• Product Code: NPT
• 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,Followup,Followup
• Report Date: 09/27/2021

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: 01/14/2023
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0010524755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/30/2021
• Supplement Dates Manufacturer Received: 07/08/2021; 08/26/2021; 09/20/2021
• Supplement Dates FDA Received: 07/09/2021; 09/09/2021; 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR