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

Model Number D-EVPROP2329US

Device Problem Failure to Advance (2524)

Patient Problem Vascular Dissection (3160)

Event Date 07/13/2022

Event Type  Injury  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the vessel was small (5.0 mm) and the delivery catheter system (dcs) was attempted to push forward.The 14 fr non-medtronic sheath would track through the vessel however the dcs would not.A dissection appeared to have occurred at the location where the dcs was getting stuck in the iliac artery.Two stents were deployed to seal the dissection from the level of the internal iliac artery to the access site in the mid femoral head.No additional adverse patient effects were reported.

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.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 fully closed.The device was returned with the end cap/screw gear snap fit connected.The capsule was intact with no evidence of damage, with a slight bend to the distal tip of the nose cone.Slight delamination was observed over the nitinol reinforcing frame along the proximal end of the capsule.On retraction of the capsule via the rotation of the deployment knob, the valve deployed with an infold.The deployment knob retracted and advanced the capsule.The trigger moved to fully advance and retracted positions and locked in place when released.The tip-retrieval mechanism was intact.The inner member shaft and spindle hub was intact with no evidence of damage.Conclusion: the investigation is in progress.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

Conclusion: the subject delivery catheter system (dcs) was returned to medtronic for analysis.A slight bend to the distal tip of the nose cone was observed in analysis.It is possible that this occurred during the delivery attempt.Delamination was observed on the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy.There was no other damage noted to the remainder of the device.The reported event indicates that the vessel was small (5.0 mm) and the dcs was attempted to push forward.The 14 fr non-medtronic sheath would track through the vessel however the dcs would not.Difficulties advancing the dcs through the access vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.A dissection appeared to have occurred at the location where the dcs was getting stuck in the iliac artery.Vascular access related complications, such as dissection, are a known potential adverse patient effect per the evolut pro+ 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.).A device history record (dhr) review was performed on the dcs and 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.The dhr review did not show any findings related to this event.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.Updated 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: 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: 15104035
• MDR Text Key: 296589855
• Report Number: 2025587-2022-02099
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000207854
• UDI-Public: 00763000207854
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2024
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0011215062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 10/02/2022; 10/05/2022
• Supplement Dates FDA Received: 10/05/2022; 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2022
• 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): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female