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

Model Number D-EVPROP23-29

Device Problems Material Separation (1562); Failure to Advance (2524)

Patient Problems Unspecified Infection (1930); Pain (1994); Vascular Dissection (3160)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: the main component of the system.Other relevant device(s) are: product id: e vproplus-26us, serial/lot #: (b)(4), ubd: 18-feb-2024, udi#: (b)(4).Product analysis: the valve remains implanted and the dcs was discarded, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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.

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the delivery catheter system (dcs) could not pass through the aortic arch due to tortuous blood vessels.The guidewire was changed to a non-medtronic guidewire and an attempt was made using a snare but was unable to pass through the aortic arch.Damage to the capsule portion of the dcs was observed when the snare was used.The dcs capsule was reported as ¿cracked¿/torn but not separated.Subsequently a 65 centimeter (cm) non-medtronic introducer sheath was used with a new valve and dcs which was implanted successfully.Computed tomography was performed following the valve implant and a dissection was observed in the aortic arch.Per the physician, the dissection might have occurred during the dcs operation and the tortuous blood vessels may have contributed.Conservative treatment was reported as follow-up.No other intervention reported.No additional adverse patient effects were reported.Additional information was received that during the valve implant procedure the patient reported back pain and not treatment was reported.Approximately one month following the valve implant, the patient reported abdominal pain and was hospitalized.The following day, blood in stool and white blood cells increased to 13,000 and antibiotics was administered.The patient improved and was discharged approximately ten days later.No additional adverse patient effects were reported.

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.Difficulties advancing the delivery catheter system (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 tortuous blood vessels.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be conclusively confirmed with the limited information available.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.Vascular access related complications, such as 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.).Based on the limited information available, an assignable root cause of the vascular complication cannot be determined and a relationship to the dcs could not be established.Per the physician, the dissection might have occurred during the dcs operation and the tortuous blood vessels may have contributed.There is no information to suggest that a device malfunction or a failure to meet manufacturing specifications was related to these events.As the dcs was not returned to medtronic for analysis and no images of the capsule damage were provided for review, a root cause of the damage to the capsule cannot be determined.There is no information to suggest that a device malfunction or a failure to meet manufacturing specifications was related to the damage.Infection is a procedural complication and is a known potential adverse effect per the ifu.In addition, hospital-acquired infections resulting from transcatheter aortic valve implantation (tavi) procedures can generally be attributed to a number of patient and procedure-related factors rather than device-related factors.Updated: 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.

• 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: 16033036
• MDR Text Key: 305976430
• Report Number: 2025587-2022-03678
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-EVPROP23-29
• Device Catalogue Number: D-EVPROP23-29
• Device Lot Number: 0010880161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• 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): Hospitalization
• Patient Age: 93 YR
• Patient Sex: Female
• Patient Weight: 40 KG