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

Model Number ENVPRO-16

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

Patient Problem Vascular Dissection (3160)

Event Date 05/02/2022

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the delivery catheter system (dcs) was unable to be advanced across the annulus due to calcification of the aortic root, sinotubular junction (stj), and annulus.Force was used to try to cross the valve however this was unsuccessful.The catheter was twisted while in the ascending aorta in an attempt to advance the dcs, but this was also unsuccessful.The dcs was removed and the non-medtronic guidewire was exchanged with another non-medtronic guidewire that was stiffer.Upon removal of the dcs from the patient's body, the dcs was noted to be twisted and on release of the valve by turning the deployment knob, the wire lumen in the distal catheter tip was bent at a 90 degree angle. the physician requested a replacement valve and dcs.A second dcs and valve were used, and the valve was deployed with no issues.Post implant, a dissection was noted and a femoral covered stent was implanted.Per the physician, the cause of the dissection was femoral calcification.It was reported that the first dcs contributed to the dissection.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.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 handle of the subject delivery catheter system (dcs) was intact.The deployment knob appeared to retract and advance the capsule.The trigger moved to fully advance 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 full length of the capsule.The separated nosecone was not returned with the dcs.The inner member was separated from the dcs slightly distal to the spindle hub.A kink was noted along the inner member near the separation site.The separation occurred 12mm distal to the paddle pockets.Conclusion: the investigation is pending.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 dcs was returned to medtronic for analysis.Images were received for review.The reported event indicates that the dcs was unable to be advanced across the annulus due to calcification of the aortic root, sinotubular junction, and annulus.Force was used to try to cross the valve however this was unsuccessful.The catheter was twisted while in the ascending aorta in an attempt to advance the dcs, but this was also unsuccessful.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.In this case, it was noted that there was calcification of the aortic root, sinotubular junction, and annulus.This indicates that the probable cause of the advancement difficulties was patient anatomy.The subject dcs was returned.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 returned with the inner member separated from the dcs.The separation would be consistent with a kink on the inner member reported in the event description.No images were provided which show the separation of the inner member, however the event description states that force was used when attempting the advance the dcs, and that the dcs was twisted while in the ascending aorta.The evolut system ifu instructs "do not force passage".Persistent force on the catheter can cause damage to the catheter.Twisting the catheter can also cause damage to the inner member of the catheter.Post implant, a dissection was noted and a femoral covered stent was implanted.Vascular access related complications, such as bleeding and dissection, are a known potential adverse patient effect per the evolut system ifu and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).Per the physician, the cause of the dissection was femoral calcification.Three procedural images were provided for review.No images were provided of the procedure using the first dcs.The root cause of the dissection could not be confirmed, however the provided images do confirm that there was a heavy calcium burden in the right femoral artery, which could have led to the dissection in question.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.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.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
• 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: 14434406
• MDR Text Key: 292034536
• Report Number: 2025587-2022-01390
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2022

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: 01/18/2024
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: 0011026559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 07/14/2022; 09/16/2022
• Supplement Dates FDA Received: 08/10/2022; 09/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• 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: 79 YR
• Patient Sex: Male