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

Model Number ENVPRO-16

Device Problems Difficult or Delayed Positioning (1157); Detachment of Device or Device Component (2907); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) handle was intact.The deployment knob was able 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.Several voids were observed over the nitinol reinforcing frame along the full length of the capsule.The device was returned with the nose cone missing.On retraction of the capsule, it was observed that the inner member was detached from the spindle hub.The inner member was not returned with the device.Conclusion: the investigation is in progress.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of a transcatheter bioprosthetic valve with this delivery catheter system (dc s), using the inline sheath, an extra clicking noise from the handle of the dcs was noted.The deployment was reported to be not as smooth as usual.The valve was recaptured twice for repositioning and successfully implanted on the third deployment.Upon exiting the femoral artery, no resistance was noted but the system had not been fully closed and the nose cone detached from the dcs.A snare was used to remove the nose cone from the patient.It was reported to be the first time that the facility had used this dcs model.The minimum access vessel diameter was reported to be 7 mm.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the device was returned for analysis.No images were received for review.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.During analysis, a squeaking noise was noted; however, it was not indicated that this issue occurred during the reported incident.Voids, which indicate delamination between the capsule outer polymer and the nitinol frame, typically occur when the capsule is subjected to a bending force.A void may occur over the spindle/paddle interface if a valve was misloaded; however, voids may also occur due to tracking/positioning in the patient anatomy.In the absence of fluoroscopic load check or procedural images, the source of these voids cannot be determined.Additional information received indicated ¿it's dislodgement was 100% at the fault of the user who forgot to close the system before removing from the patient.¿ the device instructions for use (ifu) instructs that the capsule must be fully closed prior to removal.Recapturing is a feature of the device which allows for additional attempts to accurately position the valve.Various factors can affect valve positioning, including the patient anatomy or physician technique.Positioning difficulties do not typically indicate a device manufacturing issue.It is possible that multiple attempts to position the valve, coupled with the speed of the recaptures, may have led to increased tension in the system and higher deployment forces.Another possible cause of clicking could be delivery catheter system handle clutching.When this occurs, as the handle is turned, instead of the slider tooth following the thread in the screw gear, the force in the system pushes the slider tooth over the top of the screw gear thread.This is accompanied by a clicking sound.Historically, a misloaded valve is a known cause of high forces resulting in clutching.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7895245
• MDR Text Key: 120921958
• Report Number: 2025587-2018-02472
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2020
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: 0009012904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Date Manufacturer Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 48