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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 10621
Device Problems Break (1069); Activation Failure (3270)
Patient Problems Embolism (1829); No Code Available (3191)
Event Date 04/07/2020
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that the device fractured and required surgery for removal.The left coronary artery was cannulated via the right radial artery.The target lesion was successfully pre-dilated using a 2.0 x 20mm balloon at 6 atmospheres, resulting in a good lumen.A 3.50 x 28mm synergy ii drug-eluting stent was advanced for treatment.During stent deployment the balloon did not inflate and it was noted that the device had fractured.The distal end of the delivery system, including the stent, embolized with the under-expanded stent in the distal to middle third of the anterior descending artery, and the balloon in the left main trunk.After several unsuccessful attempts to rescue the embolized delivery system using intracoronary angioplasty and foreign body extraction, the patient underwent surgery to remove the device and perform a coronary bridge.The surgery was success and afterward the patient was stable, awaiting discharge.The patient was reported as stable throughout the whole process.
 
Event Description
It was reported that the device fractured and required surgery for removal.The left coronary artery was cannulated via the right radial artery.The target lesion was successfully pre-dilated using a 2.0 x 20mm balloon at 6 atmospheres, resulting in a good lumen.A 3.50 x 28mm synergy ii drug-eluting stent was advanced for treatment.During stent deployment the balloon did not inflate and it was noted that the device had fractured.The distal end of the delivery system, including the stent, embolized with the under-expanded stent in the distal to middle third of the anterior descending artery, and the balloon in the left main trunk.After several unsuccessful attempts to rescue the embolized delivery system using intracoronary angioplasty and foreign body extraction, the patient underwent surgery to remove the device and perform a coronary bridge.The surgery was success and afterward the patient was stable, awaiting discharge.The patient was reported as stable throughout the whole process.
 
Manufacturer Narrative
Device is a combination product.A synergy ous mr 3.50 x 28mm stent delivery system catheter was returned for analysis without the stent and without the balloon and tip sections of the device.A visual and tactile examination of the hypotube shaft found multiple kinks along the length of the shaft.A visual examination of the outer and inner lumen and mid-shaft section found a midshaft extrusion break and kink 1084mm distal from the distal end of strain relief exposing the hypotube laser cut and core wire section.A kink in the exposed core wire was also noted at the distal end of the laser cut section.No other issues were identified during the product analysis.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10043331
MDR Text Key190520747
Report Number2134265-2020-05413
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/29/2020
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
Device Operator Health Professional
Device Expiration Date03/17/2021
Device Model Number10621
Device Catalogue Number10621
Device Lot Number0024520326
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2020
Initial Date Manufacturer Received 04/16/2020
Initial Date FDA Received05/11/2020
Supplement Dates Manufacturer Received07/08/2020
Supplement Dates FDA Received07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age51 YR
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