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

Model Number D-EVPROP34

Device Problems Failure to Advance (2524); Patient Device Interaction Problem (4001)

Patient Problems Ischemia (1942); Rupture (2208); Cardiogenic Shock (2262); Low Cardiac Output (2501)

Event Date 07/11/2022

Event Type  Death  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the delivery catheter system (dcs) was not able to advance through the patient's common iliac artery.The dcs was withdrawn and a non-medtronic valve was successfully implanted.Following the valve implant, a rupture of the external iliac artery occurred.According to the physician, the rupture of the external iliac artery took place while attempting to advance the medtronic dcs through the stent in the common iliac artery.The patient subsequently died.The cause of death was reported as hemorrhagic shock as a result of the external iliac artery rupture, followed by cardiac shock due to general ischemia and low output.Of note, the patient had peripheral artery disease, with a stent at the aortic bifurcation/common iliac artery and calcification of the external iliac artery.The minimum access vessel diameter was reported as 4.4mm.

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

Additional information was received clarifying that although the rupture was suspected to have occurred while attempting to advance the medtronic delivery catheter system (dcs), the rupture was not detected until after the system was withdrawn and a non-medtronic valve had been successfully implanted.Upon receipt at medtronic¿s quality laboratory, the handle was intact.The delivery catheter system (dcs) was received with the capsule fully closed.Delamination was observed over the nitinol reinforcing frame along the distal end to the proximal end of the capsule.The inner member shaft and spindle hub was intact with no evidence of damage.The deployment knob retracted and advanced the capsule.The trigger moved to fully advanced 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.The valve was received loaded in the capsule of the dcs.On retraction of the capsule via the rotation of the deployment knob, the valve deployed as expected.The reported event for unable to advance could not be confirmed in the analysis.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 dcs was returned to medtronic for analysis.Delamination was observed over the nitinol reinforcing frame along the distal end to the proximal end of the capsule, which typically occurs when the capsule is subjected to a bending force, potentially after tracking through tortuous anatomy.Procedural images were provided for review.48 images were contained within the angiographic study provided for this event.The images received show that a percutaneous balloon angioplasty of the left common iliac region was performed after five aggressive attempts to traverse through the anatomy with the dcs.There are three more recorded attempts to get the dcs to cross without success.The images provided show the presence of a prior stent in the left common iliac, as reported.In the next image, a non-medtronic bioprosthetic valve is introduced, followed by an image of a massive perforated left external artery.It appears the implant team continued for the next four images to deploy the non-medtronic bioprosthetic valve and not address the perforation.After implant imaging, the next image is of the left iliac to proximal femoral artery showing the perforated left external iliac.No wire is across on the left side.It appears they try to access the left common femoral again with a cine of a needle moving around.There is an image of an inflated balloon of unknown size in the left common iliac proximal to perforated external artery.There is imaging of compressions being given to patient.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 the patient had peripheral artery disease, with a stent at the aortic bifurcation/common iliac artery and calcification of the external iliac artery.It was reported that the minimum access vessel diameter was 4.4mm.As per the evolut pro plus instructions for use (ifu), ¿patients must present with trans arterial access vessels with diameters that are =6.0 mm when using model d-evprop34us¿.This indicates off label use.With this information, the probable root cause of the advancement issues is the diameter of the access vessel.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.Vascular complications, such as rupture, are a known potential adverse patient effect per the evolut pro plus system ifu, and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).In this case, it is visible from the procedural images provided, that extreme force was used to advance the dcs through the access vessel.It is probable that the aggressive attempts to traverse the dcs through the anatomy caused the rupture, however this cannot be conclusively confirmed.According to the physician, the rupture of the external iliac artery took place while attempting to advance the medtronic dcs through the stent in the common iliac artery.There is no information to suggest that a device malfunction or a failure to meet manufacturing specifications was related to these events.The rupture is visible on the procedural images following the withdrawal of the dcs, however, the physician elected to continue the procedure and a 29mm non-medtronic valve was implanted.The patient subsequently died.The cause of death was reported as hemorrhagic shock as a result of the external iliac artery rupture, followed by cardiac shock due to general ischemia and low output.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.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: 15102621
• MDR Text Key: 296567406
• Report Number: 2025587-2022-02094
• 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: 10/11/2022

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: 10/29/2022
• Device Model Number: D-EVPROP34
• Device Catalogue Number: D-EVPROP34
• Device Lot Number: 0010917716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 08/31/2022; 10/04/2022
• Supplement Dates FDA Received: 10/05/2022; 10/11/2022
• Date Device Manufactured: 10/29/2021
• 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): Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 85 KG