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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 Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
Event Date 05/26/2021
Event Type  Injury  
Event Description
(b)(6) registry. It was reported that coronary arteriosclerosis occurred. In (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed. The target lesion 1 was located in proximal left anterior descending artery (lad) extending up to mid lad with 90% stenosis and was 36 mm long, with a reference vessel diameter of 3. 5 mm. The target lesion 1 was treated with pre-dilatation and placement of 2. 75 mm x 24 mm overlapped on to 3. 50 mm x 16 mm synergy stents system. Following this intervention, post dilation was performed with 0% of residual stenosis. Three days later, the subject was discharged on aspirin and ticagrelor. Two weeks and four days later, subject underwent staged procedure. The target lesion 1 was in proximal right coronary artery (rca) extending up to right posterior descending artery (r-pda) with 100% stenosis and was 106 mm long, with a reference vessel diameter of 3 mm. The target lesion 1 was treated with pre-dilatation and placement of 2. 25 mm x 32 mm overlapped on to 3. 00 mm x 38 mm and 3. 00 mm x 38 mm synergy stents system. Following this intervention, post dilation was performed with 0% of residual stenosis. Two days later, the subject was discharged on aspirin and ticagrelor. In (b)(6) 2021, the subject was diagnosed with coronary arteriosclerosis and was hospitalized on same day for further evaluation and treatment. Angiography without revascularization was performed. Two days later, the event was recovered and resolved. The subject was discharged on the same day on aspirin and ticagrelor. Furthermore, it was noted that "in-stent restenosis occurred in the experimental stent for both. ".
 
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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 Key12064145
MDR Text Key258299277
Report Number2134265-2021-07975
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 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received06/08/2021
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: 06/24/2021 Patient Sequence Number: 1
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