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

Model Number ENVPRO-14

Device Problems Difficult or Delayed Positioning (1157); Peeled/Delaminated (1454); Material Separation (1562)

Patient Problem Vascular Dissection (3160)

Event Date 03/08/2022

Event Type  Injury  

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 was recaptured once due to deep depth.During the second deployment attempt, a good position of the valve was achieved.The delivery catheter system (dcs) was removed through the femoral artery and through the 18 f non-medtronic sheath.Damage of the capsule of the dcs was observed.A dissection of the femoral artery was reported to have occurred at the end of the procedure and two uncovered stents were implanted.The cause of the dissection was not reported.Of note, the patient had a minimum access vessel diameter of 6.8, slight tortuosity and mild calcification.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) handle appeared intact.The device was received with the capsule fully closed.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 appeared 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 of the capsule.Small sections of delamination were also noted along the distal and proximal side of the capsule.The device was rotated by 90° and damage on the polymer material surface was noted along the length of the capsule.A kink was observed along the proximal side of the inner member shaft near the paddle pockets.The reported event for positioning difficulties and capsule separation could not be confirmed in the analysis.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.Damage on the polymer material surface was noted along the length of the capsule.No other damage was observed on the subject dcs.There was no evidence to support a capsule separation had occurred.It was reported that slight tortuosity and mild calcification was present in the patient¿s anatomy which suggests that the capsule damage may be related to anatomy.Delamination was observed on the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through tortuous anatomy.A kink was observed in the inner member shaft, however the description of the event does not indicate that this damage occurred during the reported issue.The kink may have occurred during loading of the valve, or possibly during the recapture of the valve.No other damage was observed on the subject dcs.Vascular access related complications, such as bleeding and dissection, are a known potential adverse patient effect per the device 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.).There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.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.Updated h6.Correction: b1 <(>&<)> h1.Product analysis confirmed that capsule damage occurred, however, there is no indication that a capsule s eparation occurred.Therefore, this event does not meet reporting criteria as a product problem.B1 was updated to reflect that this event is being reported as an adverse event only.H1 was updated as the type of reportable event is a serious injury.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: 13777425
• MDR Text Key: 289971250
• Report Number: 2025587-2022-00690
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: ENVPRO-14
• Device Catalogue Number: ENVPRO-14
• Device Lot Number: 0010978122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2021
• 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): Required Intervention
• Patient Sex: Female