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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 Obstruction of Flow (2423)
Patient Problems Angina (1710); Restenosis (4576)
Event Date 06/13/2021
Event Type  Injury  
Event Description
(b)(6) registry. It was reported that stable angina and restenosis occurred. In (b)(6) 2019, the subject with stable angina was referred for cardiac catherization and the index procedure was performed on the same day. The target lesion 1 was located in the mid left anterior descending (lad) artery with 90% stenosis and was 39 mm long, with a reference vessel diameter of 4. 00 mm. The target lesion 1 was treated with pre-dilatation followed by placement of 3. 50 mm x 16 mm overlapped with 4. 00 mm x 28 mm synergy stents system. Following post-dilatation, the residual stenosis was 0%. The following day, the subject was discharged on aspirin and clopidogrel. In (b)(6) 2021, the subject presented with angina and symptoms of ischemia was diagnosed with stable angina pectoris and was hospitalized on the same day for further evaluation and treatment. Two days later, the subject was referred for coronary angiography which revealed 95% stenosis noted in proximal lad extended to distal lad which had previously placed study device in mid lad was treated with percutaneous coronary intervention (pci), target-vessel revascularization (tvr). Post intervention, residual stenosis was 0%. At the time of reporting, the outcome of the event was considered to be recovering and resolving. Two days later, the subject was discharged on aspirin and clopidogrel.
 
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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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12558466
MDR Text Key274240805
Report Number2134265-2021-12183
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2020
Device Model Number10618
Device Catalogue Number10618
Device Lot Number0023503331
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/30/2021 Patient Sequence Number: 1
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