MAUDE Adverse Event Report: MEDTRONIC IRELAND EVOLUTFX CATHETER DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 2329

Device Problem Difficult to Advance (2920)

Patient Problems Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Dysphasia (2195); Stenosis (2263); Diminished Pulse Pressure (2606); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/08/2022

Event Type  Death  

Event Description

Case summary per cardiovascular surgeon: the patient was taken to the hybrid catheterization laboratory.Access was obtained in the left and right common femoral artery and the left common femoral vein.Pigtail catheter was placed in the aortic root.Temporary pacemaker was placed and tested.No sentinel device was used, as her radial arteries were quite small and unusable.Sheath was placed in the right common femoral artery.It was stenotic, but the sheath went in with minimal difficulty.The valve was then crossed; 18 meds z-med balloon was used for balloon aortic valvuloplasty and then the sheath was removed, and the sheath was placed with the corevalve delivery system.The valve was placed across the annulus and deployed in an inline fashion.Positioning was excellent.There was no perivalvular leak.The delivery system was then removed, and the femoral artery closed with a perclose device, which was effective.Starclose was used in the left side.Aortic and iliac angiography was performed, which did show a stenotic iliac above the level of the access site.This was dilated.The sheath was removed, and the vessel closed with previously placed perclose device.At the end of the procedure the patient did develop a aphasia, a stroke code was called and urgent thrombectomy completed.Detailed groin closure per interventionalist: i then withdrew the delivery sheath from the right femoral artery and the perclose devices were tightened.There was total hemostasis at this femoral site.From the left side i advanced a pigtail catheter over the aortic bifurcation and perform selective angiography of the right external iliac and common femoral vessels.This revealed 90% stenosis of the distal right external iliac artery.Using a glidewire advantage across the lesion.I then exchanged sheath for a 6 french balkan sheath.Through this sheath i advanced a 6.0 x 4 evercross balloon.I did a single balloon dilation of the lesion with 40% residual stenosis.I removed the left femoral artery sheath and placed a starclose device.Post stroke intervention summary of care per mda: patient was unstable with low bps at conclusion of stroke intervention.She responded initially to pressors (phenylephrine and norepinephrine), iv fluid bolus, and first unit of prbc.A second unit of blood was started, phenylephrine weaned off, norepinephrine turned down, and preparations made to transport to ct scanning.As patient was leaving procedure room, bp abruptly plummeted.Patient returned to cath lab for resuscitation.No pulse found.Code blue activated, cpr / acls initiated.Rhythm was pea, then v-fib, which was shocked 2-3 times, then back to pea.Despite prolonged resuscitation efforts, rapid ivf and blood administration, no rosc was achieved.Pupils were fixed and dilated.Efforts terminated at 1209.

• Brand Name: EVOLUTFX CATHETER DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC IRELAND
• MDR Report Key: 15986937
• MDR Text Key: 305521039
• Report Number: MW5113789
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2329
• Device Lot Number: (10) 0011424293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLN TYSHAK 2-MED *DISC 63309; CATH INIFINTI PIGT 6FR 110C; CATH SWAN GANZ FEM PACING; CBL PACING PAC-LOC DISP; DEV VASC CLSR PERCLOSE PR; GDWIRE ADVANTAGE 0.035 260; GDWIRE FIX HD ST 0.035 145C; GDWIRE JTIP 6MM 0.035 150C; GDWIRE SAFARI 2 CURV SM 275; KT INFL DEV 40CC N 622513 CA; SHEATH AVANTI MS PLUS 6.5 FR; SHEATH BALKIN HYDRPHL 6F; SLV REPOS HEMO 9FR 60C; STOPCOCK 3W 1050 PSI LL70; SYSLOAD EVOLUTFX 23/26/29
• Patient Outcome(s): Required Intervention; Life Threatening; Death
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White