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; CORONARY DRUG-ELUTING STENT
  • 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; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10617
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/18/2022
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending (lad) artery.After advancing a non-boston scientific (bsc) guide catheter, a non-bsc guidewire was used to cross the lesion.Predilatation was performed with a 2 x 12mm balloon catheter.A 3.00 x 38 synergy drug eluting stent was advanced and deployed in the proximal lad.A 2.75 x 12 synergy drug eluting stent was advanced to treat the distal lad.However, during introduction, the stent hypotube broke inside the guide catheter.The device was removed and the procedure was completed with another of same device.No patient complications were reported and the patient was stable post procedure.
 
Event Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending (lad) artery.After advancing a non-boston scientific (bsc) guide catheter, a non-bsc guidewire was used to cross the lesion.Predilatation was performed with a 2 x 12mm balloon catheter.A 3.00 x 38 synergy drug eluting stent was advanced and deployed in the proximal lad.A 2.75 x 12 synergy drug eluting stent was advanced to treat the distal lad.However, during introduction, the stent hypotube broke inside the guide catheter.The device was removed and the procedure was completed with another of same device.No patient complications were reported and the patient was stable post procedure.
 
Manufacturer Narrative
Device evaluated by mfr.: a partial stent delivery system was returned for analysis.Part of proximal shaft was returned for analysis.No manifold hub was returned with the device.Examination of the crimped stent via scope found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal marker bands.The crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube identified a break on the hypotube shaft located at 75cm distal to the distal end of strain relief as well as multiple kinks.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.No issues were noted.No other issues were identified during the product analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYNERGY
Type of Device
CORONARY 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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14250890
MDR Text Key290389658
Report Number2134265-2022-04642
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/29/2023
Device Model Number10617
Device Catalogue Number10617
Device Lot Number0027096250
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE CATHETER USED: 6F EBU 3.5; GUIDE CATHETER USED: 6F EBU 3.5; GUIDEWIRE USED: WHISPER MS; GUIDEWIRE USED: WHISPER MS
-
-