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

Model Number D-EVPROP23-29

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Rupture (2208); Vascular Dissection (3160); Unspecified Tissue Injury (4559)

Event Date 12/29/2021

Event Type  Death  

Event Description

Medtronic received information that during the attempted implant of this transcatheter bioprosthetic valve, the delivery catheter system (dcs) was not able to pass the aortic arch.To avoid force on the system and anatomy, the physician changed the orientation by 90 degrees in the descending aorta to provide a potential better alignment of the dcs.However, the dcs was still not able to pass the aortic arch.Two different non-medtronic guidewires were attempted as well without successful arch passing.Hypotension presented and an angiogram performed.Extravasation was observed in the aortic arch.A thoracic endovascular aortic repair (tevar) was successfully performed.However, the blood pressure did not recover, and the patient died.

Manufacturer Narrative

Product analysis: the device was discarded, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received that extravasation was noted consistent with an aortic dissection with a rupture.It was reported that pre-procedural computed tomography (ct) scan showed a mixed plaque in the aortic arch.It was reported that most likely the tip of the delivery catheter system (dcs) got caught behind the calcium in this plaque and caused the aorta to rupture focally.It was reported that the non-medtronic guidewire passed the arch without injury and was placed in the left ventricle apex without complication.The exchange of guidewires was done over a pigtail catheter and therefore did not contribute to the rupture.A transfusion and fluid administration were performed for the hypotension.Vasopression was used in moderation in order not to increase the size of the rupture due to the high blood pressure.Resuscitation was also applied.The cause of death was exsanguination.Per the physician, the stiffness of the dcs capsule and patient anatomy may have contributed to the injury and subsequent death.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 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 images were provided to medtronic for review; however, the level of calcification was unable to be determined from the provided images.The reported event indicates that the delivery catheter system (dcs) was unable to pass the aortic arch.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.The physician changed the orientation by 90 degrees in the descending aorta to provide a potential better alignment of the dcs.However, the dcs was still not able to pass the aortic arch.It was reported that pre-procedural computed tomography (ct) scan showed a mixed plaque in the aortic arch.It was reported that most likely the tip of the delivery catheter system (dcs) got caught behind the calcium in this plaque.This indicates that the probable cause of the advancement difficulties was patient anatomy.Hypotension presented and an angiogram performed.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.A transfusion and fluid administration were performed for the hypotension.Extravasation was observed in the aortic arch.It was reported that when the dcs was attempted to cross the aortic arch, the tip of the dcs got caught behind calcium and caused the aorta to rupture focally.A thoracic endovascular aortic repair (tevar) was successfully performed.However, the blood pressure did not recover, and the patient died.Vascular access related complications, such as rupture, dissection, and patient death, 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.).Vasopression was used in moderation in order not to increase the size of the rupture due to the high blood pressure.Resuscitation was also applied.The cause of death was exsanguination.Per the physician, the stiffness of the dcs capsule and patient anatomy may have contributed to the injury and subsequent death.The subject dcs was not returned for product analysis, therefore the reported stiffness of the capsule could not be confirmed.A pre-procedural computed tomography (ct) scan showed a mixed plaque in the aortic arch.This indicated that the probable cause was patient anatomy.Updated data: h6 - method, results and conclusion codes g1 - first name, last name, email and phone number.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.

• 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: 13168586
• MDR Text Key: 283246870
• Report Number: 2025587-2022-00019
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/25/2022

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: 09/30/2022
• Device Model Number: D-EVPROP23-29
• Device Catalogue Number: D-EVPROP23-29
• Device Lot Number: 0010876138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 01/13/2022; 03/16/2022
• Supplement Dates FDA Received: 01/14/2022; 03/25/2022
• Date Device Manufactured: 09/30/2021
• 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: 83 YR
• Patient Sex: Female