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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 Fracture
Event Date 09/05/2019
Event Type  Injury  
Manufacturer Narrative

Device is a combination product. Age at time of event: 18 years or older.

 
Event Description

It was reported that stent fracture occurred. Vascular access was obtained via the right femoral artery. The target lesion was located in the non-tortuous and non-calcified proximal left anterior descending artery. Following predilatation with a 3. 0 x 12 mm nc emerge balloon, a 4. 00 x 16 synergy drug-eluting stent was deployed for 20 seconds at 16 atmospheres (atm) expanding to 4. 30 mm. The delivery system balloon was then inflated for 10 seconds at 14 atm expanding to 4. 22 mm. Post dilation was performed with a 4. 5 mm x 12 mm nc emerge balloon at 18 atm expanding to 4. 70 mm. After deployment a stent boost was used to check and it was noticed that there was a gap in the stent which suggested signs of stent fracture. Additional post dilation was performed with a 5. 0 x 8 mm balloon inflated for 10 seconds at 14atm and a 5. 5 x 8 mm balloon inflated at 8atm and 12 atm. A 5. 5 x 8 mm nc emerge balloon was also inflated for 6 seconds at 8atm and for 14 seconds at 12 atm. Intravascular ultrasound imaging was performed and an irregularity in the stent struts was noticed. The patient status was stable and they were under observation.

 
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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 Key9119268
Report Number2134265-2019-11224
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10618
Device Catalogue Number10618
Device LOT Number0023726380
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/20/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/25/2019
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: 09/25/2019 Patient Sequence Number: 1
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