MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENTINEL CEREBRAL PROTECTION SYSTEM; EMBOLIC PROTECTION DEVICE

Model Number CMS15-10C

Device Problems Difficult or Delayed Positioning (1157); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  malfunction  

Event Description

It was reported that the proximal filter moved out of position in an open state.Medical history: moderate calcification, left dominant coronary artery anatomy, low lying left coronary artery.Procedure summary vascular access for the sentinel cerebral protection system (cps) was obtained via a transradial approach.The sentinel cps was inserted.The proximal filter was deployed.The physician encountered difficulty deploying the distal filter due to the proximity of the left common carotid(lcc) to the innominate artery and a 90 degree bend about 50mm from the ostium of the lcc; however the distal filter was able to be deployed.The proximal filter was dislodged from its position in an open state and had to be recaptured and redeployed.Vascular access for the transcatheter aortic valve replacement (tavr) procedure was obtained via a transfemoral approach.Balloon aortic valvuloplasty was successfully performed with a 23mm non-boston scientific (bsc) balloon catheter, in accordance with the instructions for use (ifu).A large size acurate neo2 valve was prepared and loaded onto an acurate neo2 transfemoral (tf) delivery system (ds) in accordance with the ifu.The acurate neo2 tf ds was advanced into position to treat the 25.7mm in diameter native aortic annulus.The large acurate neo2 valve was successfully deployed.On removal of the acurate neo2 tf ds, the acurate neo2 valve moved aortically on the non-coronary cusp(ncc) side.The patient's diastolic blood pressure was maintained at 75-80mmhg despite a moderate/severe paravalvular leak of the acurate neo2 valve.The physicians elected to accept the procedure outcome pending a surgical review.The patient was stable with complaints of shoulder pain that was attributed to positioning.Echocardiography revealed no effusion with moderate left ventricular systolic dysfunction(lvsd).Repeated echocardiogram performed 15 minutes later revealed a 1cm pericardial effusion with worsening left ventricle(lv) function.The patient's saturation of peripheral oxygen (spo2) level was 85%.The patient's chest was auscultated and pulmonary edema was diagnosed.The patient required anesthetic support and was endotracheal intubated for ventilatory support.The patient was sent for computed tomography (ct) imaging.The patient further decompensated and arrested in the ct scanner requiring pericardiocentesis with urgent transfer to surgery.Resuscitation efforts continued during the transfer to surgery, but were unsuccessful.The patient died.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 3636 n. laughlin blvd, suite 1; santa rosa CA 95403
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12088675
• MDR Text Key: 259151178
• Report Number: 2134265-2021-08086
• Device Sequence Number: 1
• Product Code: PUM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: CMS15-10C
• Device Catalogue Number: CMS15-10C
• Device Lot Number: 0026680317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1