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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 10622
Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problems Chest Pain (1776); Dyspnea (1816); Edema (1820); Pulmonary Edema (2020); Tachycardia (2095); Thrombosis (2100)
Event Date 01/22/2019
Event Type  Injury  
Manufacturer Narrative

Device is combination product.

 
Event Description

It was reported that removal difficulty, shaft break, and acute thrombosis occurred. Vascular access was obtained via the femoral artery. The 70% stenosed, 38mmx3. 5mm target lesion was located in a non-tortuous, mildly calcified right coronary artery. Pre-procedure, the patient was given 300mg aspirin and 300mg clopidogrel. Intra-procedure, the patient was given tirofiban. Following pre-dilatation with a 3. 0x20mm non-bsc balloon, the stenosis remained at 50%. A total of four stents were implanted in the right coronary artery, including a 4. 0x20mm synergy, 3. 5x32mm synergy (complaint in question), 3. 5x32mm synergy and a 3. 5x38mm non-bsc stent. Post implant of the first 3. 5 x 32mm synergy ii des stent, the balloon catheter was difficult to remove from the stent and also became stuck in the guiding catheter. The shaft of the balloon was also noted to be detached/separated. Both the guiding catheter and stent balloon catheter were safely removed from the patient. A new guiding catheter was used and the procedure was successfully completed. Post procedure, the patient developed chest pain associated with dyspnea. Electrocardiography was performed immediately which revealed sinus tachycardia and subtle changes of high side wall. It appeared ventilator failure was imminent so the patient was immediately returned to the cath lab with suspected acute stent thrombosis. There was appreciated thrombotic load, not occlusive. No stent deformation was noted. Further intervention was performed with intracoronary tirofiban and the patient is reported to be stable.

 
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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 IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8362582
MDR Text Key136893578
Report Number2134265-2019-01610
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/22/2019
Device MODEL Number10622
Device Catalogue Number10622
Device LOT Number22327756
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/07/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2019
Was Device Evaluated By Manufacturer? Yes
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: 02/22/2019 Patient Sequence Number: 1
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