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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number ENVPRO-14
Device Problems Difficult or Delayed Positioning (1157); Fracture (1260); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/30/2020
Event Type  malfunction  
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, there was difficulty positioning the delivery catheter system (dcs) in the annulus due to bad alignment, a steep angle, and the dcs lying at the inner curve.More push on the non-medtronic guidewire resulted in better coaxial alignment.The first position was too deep at the left coronary cusp (lcc).A recapture was performed, and the valve was positioned in the ascending aorta in order to wait for the patient to regain hemodynamic stability.The second position was too high on the anterior coronary cusp (acc).The valve was attempted to be recaptured a second time, but a full recapture was not possible.A lot of force was felt, and the capsule and nosecone were not fully closed.The deployment knob was turned to close the dcs, and the valve was over captured, an audible noise was heard, and the proximal spine of the dcs broke near the catheter handle.Dripping blood was reported at the catheter handle.It was not possible to open the capsule again.The dcs and valve were withdrawn from the patient and replaced.The replacement valve was successfully implanted.No adverse patient effects were reported.
 
Manufacturer Narrative
Additional information was received that the femoral artery, right posterior lateral wall, and the abdominal aorta were calcified.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
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.Procedural films received for review confirmed a good valve load check and that the first valve system was attempted.The imaging provided confirmed the second valve system was implanted in a good position and the final angiogram confirmed a good result.No other imaging was provided to confirm the reported events.The subject delivery catheter system (dcs) was returned to medtronic for analysis.Delamination was observed on the capsule, which typically occurs when the capsule is subjected to a bending force potentially after tracking through patient anatomy.There was damage observed on the threading of the screw gear.This damage is consistent with increased forces in the system.High forces in the handle may cause the threading of the screw gear to become worn and damaged.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 selection.In this case, the difficulty positioning, the steep angle and the calcified anatomy may have contributed to the higher forces in the system.During analysis, the handle did not retract the capsule when it was turned, and a spine wire break was observed.Historically, torquing or manipulation of the dcs against the spine wires by the user may cause the spine wire to break.The device instructions for use (ifu) instructs the user not to rotate the dcs as is being advanced.Spine wire break is consistent with the observed inability to react the capsule using the handle.When the spine wire breaks the force from the handle is not transmitted to the capsule.The user may have torqued the device due to the reported bad alignment, the steep angle and the calcification in the femoral and aorta, which may have damaged the spine wire.However, based on the evidence available, the cause of the reported event and dcs damage cannot be conclusively confirmed.There was no other evidence of damage observed on the subject dcs.Recapturing is a feature of the device that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.It was reported that there was a steep angle which may have caused or contributed to the positioning difficulty; however, this could not be confirmed with the available evidence.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.Updated data: 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.
 
Manufacturer Narrative
Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received with the capsule fully closed and the valve loaded in the capsule.The handle of the dcs was intact.The deployment knob and trigger did not retract or advance the capsule.The tip-retrieval mechanism appeared intact.There was damage observed on the threading of the screw gear.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.The spine of the dcs was broken at the strain relief of the dcs.The valve could not be removed from the dcs.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.
 
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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 Key9662049
MDR Text Key181998902
Report Number2025587-2020-00360
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
PMA/PMN Number
P130021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/07/2021
Device Model NumberENVPRO-14
Device Catalogue NumberENVPRO-14
Device Lot Number0009959208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2020
Initial Date Manufacturer Received 01/30/2020
Initial Date FDA Received02/03/2020
Supplement Dates Manufacturer Received02/10/2020
02/27/2020
04/10/2020
Supplement Dates FDA Received02/19/2020
03/02/2020
04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age80 YR
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