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

Model Number D-EVPROP2329US

Device Problems Difficult or Delayed Positioning (1157); Device Difficult to Setup or Prepare (1487); Material Separation (1562); Difficult to Open or Close (2921)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/22/2022

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, in a patient with a horizontal aortic base and an aortic root angle of 60 degrees, it was necessary to make several corrections to the placement and position of the delivery catheter system (dcs) and guidewire.During valve implant, the first deployment attempt was shallow and the valve was recaptured.However, the recapture could not be completely performed; a gap of approximately 2cm was observed between the capsule and nose cone of the dcs.It was reported upon further review of procedural images, a bellows-shaped slack of catheter was observed on the proximal side of the paddle attachment.A second deployment attempt was made, but the left coronary cusp side was shallow relative to the non-coronary cusp side; the valve was recaptured again.During recapture, an audible noise generated from the dcs when the handle was turned in the direction of recapture.There was resistance while recapturing and the valve could not be completely recaptured.It was determined that the dcs could be collected by retracting it into the 18fr introducer sheath.While retracting the dcs, the bending of the dcs became caught in the distal end of the introducer sheath and the introducer sheath broke.The system was removed from the patient with the dcs capsule about 5cm out of the introducer sheath.Bleeding from the femoral artery access site were observed, and no additional treatment was reported.According to the physician, the bleeding was a result of delayed procedural time.The procedure time was extended 60 to 90 minutes due to the complication.Of note, it was possible a misload occurred.Upon review of the procedure, it was noted that paddle was not properly attached.The patient¿s horizontal aorta with an aortic root angle of 62-65 may have contributed to the capsule issue.A second valve and dcs were loaded and used with a new introducer sheath.No adverse patient effects were reported.

Manufacturer Narrative

The analysis completed on (b)(6) 2022 indicated a product malfunction occurred.Additional information was received on (b)(6) 2022 which indicated that a serious injury occurred.Product analysis: upon receipt at medtronic¿s quality laboratory, the device was received with the capsule partially opened.The handle was intact.The deployment knob appeared to retract and advance 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.Delamination was observed over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule and along the distal end of the capsule.There is a buckle observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.Damage is evident on the polymer material surface at distal side of the capsule.A kink is observed along the proximal side of the inner member shaft near the paddle pockets.The dcs was returned with a sheath loaded.The sheath was removed by the lab technician during product analysis in the lab and no resistance was experienced.Conclusion: the investigation is in progress.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Patient identifier 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.Delamination was observed over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule and along the distal end of the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy.A kink was observed along the proximal side of the inner member shaft near the paddle pockets.Inner member shaft kinking has historically been seen on devices when the valve has been removed at the table without the stylet in place.The stylet provides support to the inner member and maintains axial rigidity, and without the stylet in place when the valve was removed at the back table, the inner member shaft may have kinked.There is a buckle observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.Based on the investigation completed into capsule buckle events, there is no evidence that the product fails to meet specification and these events are most likely not related to a fault condition of the device.The exact root cause of capsule buckle is unknown however, patient anatomy (vessel tortuosity <(>&<)> calcification) and use conditions due to challenging anatomy (insertion angle, force required to advance, torquing of the catheter) are known potential contributing factors to capsule damage.In this case, the challenging anatomy or a potential misload may have caused or contributed to the capsule damage, but this cannot be conclusively confirmed with the evidence available.The capsule buckle resulted in the valve being unable to be completely recaptured.Historically, high forces in the system may result in unable to recapture the valve.The force in the system is a cumulative effect that can be increased by many other factors, including load quality of the valve in the capsule, bends and kinks on the shaft, tortuous anatomy and guidewire and sheath select ion.The dcs was returned with a sheath loaded.The sheath was removed by the lab technician during product analysis in the lab and no resistance was experienced.The reported event for buckle could be confirmed in the analysis.It was noted that it was possible a misload occurred.Loading of the valve is a process in which the outcome is highly dependent on the operator experience and technique; the evolut instructions for use (ifu), contains instructions to use the integrated loading bath which features a mirror to aid in loading of the valve.In addition, the ifu instructs to inspect the capsule visually and tactilely for a misloaded bioprosthesis.With the limited information available, a misload cannot be confirmed.Vascular complications, such as bleeding, are known potential adverse patient effects per the evolut system instructions for use (ifu), and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).Based on the limited information available, an assignable root cause of the vascular complication cannot be determined and the relationship to the dcs could not be established.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.Updated data: h6 - method, results and conclusion code 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
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14594213
• MDR Text Key: 293281594
• Report Number: 2025587-2022-01564
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

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: 10/29/2023
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0010917509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• 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): Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 72 KG