Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10607
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/16/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device is a combination product.
 
Event or Problem Description
It was reported that stent fracture occurred.The target lesion was located in a very calcified artery.Following pre-dilatation with a wolverine cutting balloon, a 2.75 x 38mm synergy drug-eluting stent was advanced for treatment; however, during procedure, the stent broke.No further information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10247855
Report Number2134265-2020-08290
Device Sequence Number594335
Product Code NIQ
UDI-Device Identifier08714729840404
UDI-Public08714729840404
Combination Product (Y/N)N
Initial Reporter CountryRQ
PMA/510(K) Number
P150003
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date07/02/2021
Device Model Number10607
Device Catalogue Number10607
Device Lot Number0024095364
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/16/2020
Initial Report FDA Received Date07/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-