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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10618
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Thrombosis/Thrombus (4440)
Event Date 03/02/2022
Event Type  Death  
Event Description
It was reported that a patient death occurred. An angioplasty was performed on the left main (lm) artery. A 4. 00 x 16 synergy stent was deployed in the lm artery. The patients blood pressure started to fall and abnormal electrocardiography (ecg) changes were observed. An angiogram was performed to view the lm flow, and a clot was observed in the lm. Another stent was deployed to regain flow in the lm, however, the patient passed away at the end of the procedure. It was noted that the cause of death was due to clot in the left main artery. It was further reported that the patient presented with acute chest pain, perspiration, and low blood pressure. After the 4. 00x16 synergy stent was implanted, the lesion was post dilated with a 5. 0 x 6mm balloon at 20mm pressure. Thirty minutes later while the patient was still on the cath table, the falling blood pressure ecg changes were observed. An attempt was made to deploy another stent, however, the patient passed away during the attempt to revascularize the left main artery.
 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14047136
MDR Text Key288829273
Report Number2134265-2022-04115
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10618
Device Catalogue Number10618
Device Lot Number0026758331
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/07/2022 Patient Sequence Number: 1
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