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 Problems Anemia (1706); Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199)

Event Date 11/30/2020

Event Type  Injury  

Event Description

(b)(6) study.It was reported that bleeding and anemia occurred.The patient was enrolled into the (b)(6) study 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 not on a prior regimen of aspirin or antiplatelet medications.A loading dose of clopidogrel was given the day of the procedure.After heparin was given and prior to the sentinel cerebral protection system insertion, the activated clotting time (act) was 138 sec.An introducer was placed into the radial artery and the sentinel cerebral protection system was deployed with the proximal filter into the brachiocephalic artery and the distal filter into the left common carotid artery.An arterial sheath was placed and then the native aortic valve was treated with direct deployment of a non-boston scientific valve.Post dilatation was performed.Post deployment of the non-boston scientific valve, the patient was noted with focal dissection of the anterior ascending aorta with intimal injury from the crown of the non-boston scientific valve which led to an intra mural hematoma.The event was treated with a 30 mm hemashield graft.Subsequently, an echocardiography was performed which revealed severe aortic stenosis and pericardial effusion.The pericardial effusion caused tamponade and a pericardiocentesis was performed.Open heart surgery and cardiopulmonary bypass surgery was required.The physicians attempted to implant an additional non-boston scientific valve adjacent to the previously implanted non-boston scientific valve, but ultimately, both valves were explanted and the tavr procedure was abandoned due to complications.During the index procedure, after the sentinel cerebral protection system was removed, the patient was noted with bleeding from the radial access site.The puncture site was inspected as there was pooling of blood observed and a tr band was applied.The total blood loss was noted to be 1000 ml.The patient was transfused with 8 units of blood and was recommended for a transfusion goal of greater than 21%.On the same day of the index procedure, the related event of bleeding was considered resolved.One day post index procedure, the patient was diagnosed with acute postoperative respiratory failure, post-operative cardiogenic shock, and postoperative anemia due to blood loss.This led to a prolongation of hospitalization.The patient was intubated in response to the acute postoperative respiratory failure and the post-operative cardiogenic shock was treated medically.Four days post index procedure, the patient was diagnosed with acute metabolic encephalopathy.Nine days post index procedure, the patient was discharged on 81 mg of aspirin.

Event Description

Protected tavr study.It was reported that bleeding occurred.The patient was enrolled into the protected tavr study 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 not on a prior regimen of aspirin or antiplatelet medications.A loading dose of clopidogrel was given the day of the procedure.After heparin was given and prior to the sentinel cerebral protection system insertion, the activated clotting time (act) was 138 sec.An introducer was placed into the radial artery and the sentinel cerebral protection system was deployed with the proximal filter into the brachiocephalic artery and the distal filter into the left common carotid artery.An arterial sheath was placed and then the native aortic valve was treated with direct deployment of a non-boston scientific valve.Post dilatation was performed.Post deployment of the non-boston scientific valve, the patient was noted with focal dissection of the anterior ascending aorta with intimal injury from the crown of the non-boston scientific valve which led to an intra mural hematoma.The event was treated with a 30 mm hemashield graft.Subsequently, an echocardiography was performed which revealed severe aortic stenosis and pericardial effusion.The pericardial effusion caused tamponade and a pericardiocentesis was performed.Open heart surgery and cardiopulmonary bypass surgery was required.The physicians attempted to implant an additional non-boston scientific valve adjacent to the previously implanted non-boston scientific valve, but ultimately, both valves were explanted and the tavr procedure was abandoned due to complications.During the index procedure, after the sentinel cerebral protection system was removed, the patient was noted with bleeding from the radial access site.The puncture site was inspected as there was pooling of blood observed and a tr band was applied.The total blood loss was noted to be 1000 ml.The patient was transfused with 8 units of blood and was recommended for a transfusion goal of greater than 21%.On the same day of the index procedure, the related event of bleeding was considered resolved.One day post index procedure, the patient was diagnosed with acute postoperative respiratory failure, post-operative cardiogenic shock, and postoperative anemia due to blood loss.This led to a prolongation of hospitalization.The patient was intubated in response to the acute postoperative respiratory failure and the post-operative cardiogenic shock was treated medically.Four days post index procedure, the patient was diagnosed with acute metabolic encephalopathy.Nine days post index procedure, the patient was discharged on 81 mg of aspirin.It was further reported that the bleeding event was not related to the sentinel cerebral protection system as there were no issues with the device.The bleeding was due to the non-boston scientific introducer sheath.

• 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: 11132397
• MDR Text Key: 225561530
• Report Number: 2134265-2020-18803
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2022
• Device Model Number: CMS15-10C-US
• Device Catalogue Number: CMS15-10C-US
• Device Lot Number: 0025997745
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR