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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 10606
Medical Device Problem Codes Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 08/01/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Event date was not provided so the first day of the month from the bsc aware date was being populated as event date ((b)(6) 2019).
 
Event or Problem Description
It was reported that stent dislodgment occurred.The target lesion was located in the left radial artery.A 3.50 x 32 synergy drug eluting stent and 6f guidezilla ii were advanced but it was noted that the stent got stuck in the guidezilla and came off the balloon.The stent became lodged in left radial artery and will be left in the patient.No patient complications were reported.
 
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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 Key9098456
Report Number2134265-2019-11466
Device Sequence Number2623217
Product Code NIQ
UDI-Device Identifier08714729840367
UDI-Public08714729840367
Combination Product (Y/N)N
Initial Reporter StateIN
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) 09/20/2019
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 Date05/22/2021
Device Model Number10606
Device Catalogue Number10606
Device Lot Number0023883934
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/30/2019
Initial Report FDA Received Date09/20/2019
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 Other;
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