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

Model Number D-EVOLUTFX-2329

Device Problems Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Paralysis (1997); Cardiac Tamponade (2226); Obstruction/Occlusion (2422); Vascular Dissection (3160); Pericardial Effusion (3271); Thrombosis/Thrombus (4440); Heart Block (4444)

Event Date 02/08/2024

Event Type  Injury  

Manufacturer Narrative

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, a left subclavian approach was used. a non-medtronic (18 fr gore dryseal) introducer sheath was inserted and the valve was placed without passing through the in-line sheath.After removal of the sheath, dissection of the subclavian artery was found by contrast scan.Balloon hemostasis was performed on the dissection.When the balloon was removed, the wire was pulled out and reinserted, causing the dissection to expand.A stent was placed and the procedure was completed.No additional adverse patient effects were reported.

Event Description

Additional information was received which reported that the access diameter of the right femoral was 4.0 mm.The patient's blood vessels were think, no more than 5 mm and calcification was present.According to the physician, the likely cause of the vascular injury was damage caused by the non-medtronic dryseal introducer sheath that was large for the patient's vessel size.It was also noted that the guidewire that was reinserted to treat the dissection may have exacerbated the dissection.As the physician reinserted the wire, it entered the false lumen.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that changed the event description and device relatedness of this previously reported event.There is no evidence to suggest the device caused or contributed to a death or serious injury.According to the physician, the likely cause of the vascular injury was damage caused by the non-medtronic dryseal introducer sheath that was large for the patient's vessel size.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

Updated b5.Updated h6.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received which reported that the previously reported left subclavian artery dissection progressed to the aortic arch.The aortic arch dissection was treated conservatively due to thrombus occlusion.It was noted that massive hemorrhaging due to the vascular damage//dissection at the left subclavian artery required 10 units of rcc_lr and four units of ffp to be transfused.After the patient awoke from postoperative general anesthesia, the right upper and lower limbs were paralyzed, and a magnetic resonance imaging (mri) revealed a stroke in the left middle cerebral artery (mca) region.The patient was able to walk after rehabilitation and was transferred to the hospital for rehabilitation.The stroke was reported to be related to the procedure.It was noted that the patient was extubated due to respiratory failure due to the postoperative atelectasis in the lower right lung, possibly due to the long period of general anesthesia, it was difficult to withdraw from noninvasive positive-pressure ventilation (nppv).No additional adverse patient effects were reported.

Manufacturer Narrative

Regulatory report 2025587-2024-00987 has been identified as a duplicate to this regulatory report.The previously submitted data can be referenced from regulatory report 2025587-2024-00987.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the valve (j023720) dislodged unnoticed during subclavian treatment and was snared.Per the physician, it appeared that the guidewire was left in place when the pigtail catheter that had been inserted through the lower leg was removed, or that the guidewire got caught and pulled while stuck.An ascending aorta dissection was suspected, however no dissection was visible on computed tomography (ct) scan.The team decided to implant a second valve (j120884).  subclavian approach was considered too dangerous, therefore the team switched to right transfemoral approach.The second valve (j120884) was inserted, but the guidewire appeared to stray into the stent frame and did not pass through.The patient's blood pressure decreased while the wire was being crossed again.Pericardial effusion increased, and was punctured due to cardiac tamponade.When the guidewire was inserted, it entered the false lumen and caused a large dissection.The cardiac tamponade was resolved and the valve (j120884) was placed.There were no problems with placement: the outflow side did not spread, but the paddles came off.  an 18fr introducer sheath was inserted with no problem in order to place viabahn: one viabahn was placed in the right lower limb and one viabahn was placed in the subclavian artery, near the synthetic vascular junction.  following placement of the second valve, the patient had a complete atrio-ventricular (av) block.No additional adverse patient effects were reported.Additional information was received that clarified previously reported information.Per the physician, the medtronic (confida) guidewire got caught and pulled while stuck.The guidewire was stuck because it was left in place after the pigtail catheter had been inserted through the lower leg and was withdrawn.It was further reported that a pre-implant balloon aortic valvuloplasty (bav) was performed.Patient anatomy was not a contributing factor to the dislodgement.The deployment starting point was at the bottom of the pigtail catheter, and the direction of the dislodge was aortic.Prior to valve dislodgement, the implant depth on the non-coronary cusp (ncc) was 3 millimeter¿s (mm) and the implant depth on the left coronary cusp (lcc) was 3 mm.Per the physician, the valve did not cause or contribute to the dissection.Per the physician, the delivery catheter system (dcs) and in-line sheath damaged the subclavian artery because the inline sheath did not pass through the patient¿s anatomy which necessitated for the use of an 18 french sheath.The cause of the dissection was due to smaller vessel diameters.1 day following the implant of the valve, a permanent pacemaker was implanted for complete heart block (chb).No additional adverse patient effects were reported.Additional information was received that during the valve procedure, two dissections occurred with the first delivery catheter system (dcs) used.The location of the dissection's were the subclavian artery and the femoral artery.

• Brand Name: EVOLUT FX 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: 18719670
• MDR Text Key: 335525416
• Report Number: 2025587-2024-00939
• 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,Followup,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0011993325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Date Device Manufactured: 10/12/2023
• 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): Required Intervention; Required Intervention; Disability; Hospitalization; Life Threatening