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

Model Number EVOLUTR-34-C

Device Problems Perivalvular Leak (1457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Muscle Weakness (1967); Dysphasia (2195); Cognitive Changes (2551); Valvular Insufficiency/ Regurgitation (4449)

Event Date 09/03/2019

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this 34-millimeter (mm) transcatheter bioprosthetic valve, with the initial delivery catheter system (dcs), advancement past the native valve was difficult.The non-medtronic guidewire (0.035 double curved lunderquist wire) was advanced into the left ventricle (lv) with great difficulty due to the native bicuspid valve and severe stenosis.A second non-medtronic (amplatz left 2) and straight guidewire were required to access the left ventricle.There was great difficulty with advancing the non-medtronic balloon (20 x 40 z-med balloon) due to aortic ectasia and tortuosity.The aortic annular angle was noted to be approximately 70 degrees.The valve was pre-dilated while rapidly pacing at a rate of 180 beats per minute (bpm).This initial dcs was then unsuccessful at advancing past the native valve and the system was removed.The valve was loaded for sixty minutes as advancement issues occurred.The valve was removed from the initial dcs and loaded into a second dcs.The wire was repositioned within the lv.Repositioning was difficult due to the bicuspid valve and aortoiliac tortuosity.An extra small non-medtronic wire (0.035 safari) was advanced into the left ventricle through a pigtail catheter.Advancing the dcs was unsuccessful and a second balloon aortic valvuloplasty (bav) was performed with a non-medtronic balloon a (24 x 40 z-med balloon) while rapidly pacing at a rate of 180 bpm.A non-medtronic double-curved long wire (lunderquist) was placed in the left ventricle to act as a rail to advance the dcs.The valve was deployed while rapidly pacing at a rate of 150 bpm.Due to extreme rigidity, the valve appeared supra-annular on the left coronary cusp side.The valve was subsequently recaptured three times due to positioning issues.The valve was successfully implanted on the fourth deployment.No adverse patient effects were reported as result.Following the valve implant an echocardiogram showed trace paravalvular leak.No treatment was reported.Two days following valve implant, an acute embolic neurovascular complication with residual right-sided weakness, speech and cognitive deficits were noted.The patient was not a candidate for treatment with intravenous injection of tissue plasminogen activator (tpa) as the therapeutic window of the medication had past.No treatment was provided and seven days following the implant of the valve, the event resolved without treatment.Additional information was received which indicated that the valve itself had not caused the acute embolic stroke but rather the stroke was related to the procedure and probable calcification a contributing factor.Residual right-sided weakness, speech, and cognitive deficits remained.This acute embolic stroke warranted hospitalization.The patient was discharged 5 days following admission for the acute embolic stroke.Approximately 4 years and 6 months following the event, the physician indicated the event had resolved with sequelae.No additional adverse patient effects were reported.

Manufacturer Narrative

Continuation of d10: product id envpro-16-c; product lot number 0009803583; product type: delivery catheter system; implant date na; explant date na product id envpro-16-c; product lot number 0009803583; product type: delivery catheter system; implant date na; explant date na product id ls-envpro-16-c; product lot number 0009771783; product type: compression loading system; implant date na; explant date na product id lunderquist wire; product lot/serial number unknown; product type: guidewire; implant date na; explant date na product id lunderquist wire; product lot/serial number unknown; product type: guidewire; implant date na; explant date na product id amplatz wire; product lot/serial number unknown; product type: guidewire; implant date na; explant date na product id safari wire; product lot/serial number unknown; product type: guidewire; implant date na; explant date na product id z-med; product lot/serial number unknown ; product type: vascular balloon; implant date na; explant date na product id z-med; product lot/serial number unknown; product type: vascular balloon; implant date na; explant date na.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.

• Brand Name: EVOLUT R TRANSCATHETER AORTIC VALVE
• 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: 19001411
• MDR Text Key: 338886569
• Report Number: 2025587-2024-01984
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2021
• Device Model Number: EVOLUTR-34-C
• Device Catalogue Number: EVOLUTR-34-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Date Device Manufactured: 07/29/2019
• 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): Disability; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 108 KG
• Patient Race: White