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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10600
Medical Device Problem Code Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 07/28/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device is combination product.
 
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the circumflex artery.A 2.50 x 8 synergy drug-eluting stent was selected for treatment.However, during insertion, it was noted that the stent came off the balloon.The physician used a separate balloon catheter to crush the stent in place.The procedure was completed using a different device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
SYNERGY
Common Device Name
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key7812776
Report Number2134265-2018-60359
Device Sequence Number2295114
Product Code NIQ
UDI-Device Identifier08714729839972
UDI-Public08714729839972
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/17/2018
Device Model Number10600
Device Catalogue Number10600
Device Lot Number0021319338
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/31/2018
Initial Report FDA Received Date08/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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