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

Model Number CMS15-10C-US

Device Problems Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Pseudoaneurysm (2605)

Event Date 01/07/2021

Event Type  Injury  

Event Description

(b)(6).It was reported that perforation and pseudoaneurysm occurred.The patient was enrolled into the protected tavr study(sentinel group) and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was on a prior regimen of aspirin.A loading dose of aspirin was given the day of the index procedure.After heparin was given and prior to the sentinel cerebral protection device being inserted, the activated clotting time (act) was 352 sec.An introducer sheath was placed into the radial artery and the sentinel cerebral protection device was inserted.While advancing the sentinel cerebral protection device over the ascending aorta, a perforation in the right radial mid-forearm was observed.The forearm was compressed and an attempted was made to place the sentinel cerebral protection device, but was unsuccessful.The sentinel cerebral protection device was withdrawn and the introducer sheath was upsized in an attempt to tamponade the radial artery extravasation.A blood pressure cuff was applied and inflated over the radial branchial artery, and a tr band was applied.An ace wrap was applied over the right forearm.The native aortic valve was treated with deployment of a non-boston scientific valve with good results.The patient tolerated the procedure and was transferred to the post-anesthesia care unit in stable condition.Two days post index procedure, a right upper extremity arterial doppler revealed a pseudoaneurysm of the right radial artery.Thrombin injection was recommended to thrombose the pseudoaneurysm, so that day, thrombin was injected under ultrasound guidance.Three days post index procedure, the patient was reassessed to determine if complete closure was achieved.Upper extremity arterial doppler revealed a persistent, yet smaller, right radial artery pseudoaneurysm and a small neck pseudoaneurysm.The patient was given another thrombin injection for the right radial arterial pseudoaneurysm under ultrasound guidance with successful closure.That day, the patient was also diagnosed with acute congestive heart failure and abdominal aortic aneurysm.No change to the patient's diuretic regimen was made and the patient had a stable volume status.Three days post index procedure, the patient was discharged on 81 mg of aspirin.Four days post index procedure, the event was considered resolved.

Manufacturer Narrative

B5: describe event or problem: updated.H6: device codes: updated.

Event Description

Protected tavr study(sentinel group) it was reported that perforation and pseudoaneurysm occurred.The patient was enrolled into the protected tavr study(sentinel group) and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was on a prior regimen of aspirin.A loading dose of aspirin was given the day of the index procedure.After heparin was given and prior to the sentinel cerebral protection device being inserted, the activated clotting time (act) was 352 sec.An introducer sheath was placed into the radial artery and the sentinel cerebral protection device was inserted.While advancing the sentinel cerebral protection device over the ascending aorta, a perforation in the right radial mid-forearm was observed.The forearm was compressed and an attempted was made to place the sentinel cerebral protection device, but was unsuccessful.The sentinel cerebral protection device was withdrawn and the introducer sheath was upsized in an attempt to tamponade the radial artery extravasation.A blood pressure cuff was applied and inflated over the radial branchial artery, and a tr band was applied.An ace wrap was applied over the right forearm.The native aortic valve was treated with deployment of a non-boston scientific valve with good results.The patient tolerated the procedure and was transferred to the post-anesthesia care unit in stable condition.Two days post index procedure, a right upper extremity arterial doppler revealed a pseudoaneurysm of the right radial artery.Thrombin injection was recommended to thrombose the pseudoaneurysm, so that day, thrombin was injected under ultrasound guidance.Three days post index procedure, the patient was reassessed to determine if complete closure was achieved.Upper extremity arterial doppler revealed a persistent, yet smaller, right radial artery pseudoaneurysm and a small neck pseudoaneurysm.The patient was given another thrombin injection for the right radial arterial pseudoaneurysm under ultrasound guidance with successful closure.That day, the patient was also diagnosed with acute congestive heart failure and abdominal aortic aneurysm.No change to the patient's diuretic regimen was made and the patient had a stable volume status.Three days post index procedure, the patient was discharged on 81 mg of aspirin.Four days post index procedure, the event was considered resolved.It was further reported that the pseudoaneurysm was a complication associated with the perforation.

• Brand Name: SENTINEL CEREBRAL PROTECTION SYSTEM (US)
• Type of Device: EMBOLIC PROTECTION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11306864
• MDR Text Key: 231123320
• Report Number: 2134265-2021-01457
• Device Sequence Number: 1
• Product Code: PUM
• UDI-Device Identifier: 00863229000004
• UDI-Public: 00863229000004
• Combination Product (y/n): N
• PMA/PMN Number: K192460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0026239547
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR