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

Model Number CMS15-10C-US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

B3: date of event - estimated.Literature citation: hodges ke, chemtob ra, mehta ar, pettersson gb.Peripheral cannulation and endoaortic balloon occlusion for management of porcelain aorta during cardiac surgery.J card surg.2022 dec;37(12):5513-5516.Doi: 10.1111/jocs.17159.Epub 2022 nov 15.Pmid: 36378915.

Event Description

It was reported via journal article that a pseudoaneurysm requiring repair occurred.The patient presented to the emergency department at an outside hospital due to worsening shortness of breath over the past two weeks in the setting of decompensated heart failure.The patient evaluated for surgery at that center, but was deemed prohibitively high risk due to a porcelain aorta, so the patient was transferred to another institution for a second opinion.The preoperative assessment included a computed tomography (ct) of the chest which demonstrated severe circumferential calcification of the ascending thoracic aorta, moderate calcific atherosclerosis of the arch and descending aorta, and diffuse moderate calcific changes in the abdominal aorta.Coronary angiography did not reveal any indication for coronary artery bypass surgery.Transthoracic echocardiogram (tte) revealed a normal ejection fraction of 58 percent, dilated right atrium and right ventricle with decreased right ventricle systolic function, dilated left atrium, severe mitral stenosis with a peak gradient of 30mmhg and mean gradient of 13mmhg, 2 plus mitral regurgitation with an anteriorly directed jet, 3 plus to 4 plus tricuspid regurgitation, and severe pulmonary hypertension.An electrocardiogram (ekg) revealed an accelerated junctional rhythm.The patient was evaluated by a multidisciplinary team, including cardiac surgery, cardiac anesthesiology, and interventional cardiology.The plan was redo sternotomy, mitral valve replacement, tricuspid valve, and closure of the left atrial appendage.After induction of anesthesia and insertion of appropriate monitoring devices, the left axillary artery was exposed and an 8 mm graft was sewn to the artery for cardiopulmonary bypass.A redo sternotomy was then performed with preparation for bicaval venous cannulation and limited exposure of the ascending aorta.A sentinel device was inserted for prevention of embolic strokes through an 8-fr sheath in the right brachial artery under fluoroscopic guidance by the interventional cardiology team.The larger sheath allowed for continuous arterial pressure monitoring in the right arm during endoaortic balloon occlusion to monitor for distal migration of the endoballoon.The right femoral artery was exposed, and an 8-fr sheath was placed directly in the right femoral artery.Under fluoroscopy, a non-boston scientific (bsc) guidwire and non-bsc angled catheter were advanced to the ascending aorta.The wire was exchanged for an stiff wire and a 20-fr non-bsc sheath was advanced into the proximal descending aorta.A non-bsc device was advanced through the sheath and positioned in the aortic root under tee and fluoroscopic guidance.The patient was then fully heparinized and placed on cardiopulmonary bypass.The endoballoon was inflated under tee guidance, while adenosine was administered, and cardioplegia was delivered into the root to the heart.The remainder of the surgery proceeded in a standard fashion with intermittent retrograde buckburg cardioplegia and aortic root venting through the endoballoon.The mitral valve was addressed by a transseptal approach.The 26 mm annuloplasty band from the previous surgery was removed and the native valve was replaced using a posterior leaflet chordal sparing technique.The tricuspid valve was repaired with an annuloplasty band.The left atrial appendage had been closed from within the left atrium and this closure was found to have partially reopened.This was reclosed with a pledgeted 3-0 proline suture.After the valves were addressed, the endoballoon was deflated and the heart was de-aired via the root vent in the balloon.The endoballoon and the 20-fr sheath were then removed from the right femoral artery, which was repaired with an interrupted 5-0 prolene suture with a good distal pulse.The sentinel device was removed from the right brachial artery and the patient was decannulated in standard fashion.Total cardiopulmonary bypass time was 1 h and 31 min, total time in the operating room was 8 h and 24 min.The intraoperative transesophageal echocardiogram (tee) confirmed well-functioning mitral and tricuspid valves with no residual mr or tr and preserved biventricular function.Postoperatively the patient developed a right brachial artery pseudoaneurysm from the right brachial artery sheath for which she successfully underwent primary repair.The patient received a dual-chamber pacemaker postoperatively due to a persistent high grade heart block.The postoperative course was otherwise uncomplicated, and the patient was discharged on postoperative day 12.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM (US)
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18905076
• MDR Text Key: 337676897
• Report Number: 2124215-2024-14098
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female