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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 10623
Device Problem Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/03/2023
Event Type  malfunction  
Event Description
It was reported that balloon deflation issues occurred.Vascular access was obtained via the radial artery.A 4.00 x 38 synergy drug-eluting stent was deployed to treat a de novo lesion in the non-tortuous and non-calcified right coronary artery.Post-deployment, the balloon would not deflate.Multiple unsuccessful attempts were made to deflate the balloon with the inflation device and create a vacuum.In the end, the physician succeeded in lowering the balloon pressure slightly.The balloon, with the guide catheter and the wire, was removed intact from the patient's body in an inflated state.The patient remained stable throughout the procedure with no change in their clinical condition.A diagnostic catheter revealed no damage in the artery.The stent remained in the artery and was in a good position.Once the physician confirmed everything was fine, the procedure was completed.The patient condition was good post-procedure.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy 4.00 x 38mm stent delivery system was returned for analysis.Visual, tactile, microscopic and functional analysis was performed on the device.Multiple hypotube kinks were noted along the hypotube shaft.A kink was also noted on the laser cut region, 10.4cm from port exchange.The device was returned attached to a guidewire.The inner polymer extrusion was damaged, 8.2cm from the tip of the device.The outer diameter of the guidewire was measured and was 0.0140 inches.The stent was not returned as it was implanted successfully.Balloon cones were reviewed and were subjected to positive pressure and the balloon was returned in a deflated state.Bumper tip showed no signs of distal tip damage.The device was soaked in a water bath at 37 degrees celsius and was attached to an encore inflation device.An attempt was made to inflate the balloon however, due to the bunching in the inner lumen, the balloon would not inflate nor deflate.No other device issues were noted during returned product analysis.
 
Event Description
It was reported that balloon deflation issues occurred.Vascular access was obtained via the radial artery.A 4.00 x 38 synergy drug-eluting stent was deployed to treat a de novo lesion in the non-tortuous and non-calcified right coronary artery.Post-deployment, the balloon would not deflate.Multiple unsuccessful attempts were made to deflate the balloon with the inflation device and create a vacuum.In the end, the physician succeeded in lowering the balloon pressure slightly.The balloon, with the guide catheter and the wire, was removed intact from the patient's body in an inflated state.The patient remained stable throughout the procedure with no change in their clinical condition.A diagnostic catheter revealed no damage in the artery.The stent remained in the artery and was in a good position.Once the physician confirmed everything was fine, the procedure was completed.The patient condition was good post-procedure.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18030382
MDR Text Key326860534
Report Number2124215-2023-57629
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/17/2024
Device Model Number10623
Device Catalogue Number10623
Device Lot Number0028754927
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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