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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT Back to Search Results
Lot Number 0031838065
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2023
Event Type  Injury  
Event Description
It was reported that removal difficulty removal and shaft break occurred requiring additional intervention.The target lesion was located in the non-tortuous and moderately calcified proximal right coronary artery.A 5.00 x 32mm synergy megatron drug-eluting stent (des) was implanted successfully.During the removal of the delivery system, the balloon became stuck.Due to the catheter shaft stretching from pulling, the shaft broke proximal to the stent balloon but distal to the proximal shaft inside the patient.Part of the shaft was removed, but the balloon was still in the body.The detached portion was trapped in the guide with a trapper device and pulled out as a single system in a partially inflated state.The procedure was completed with a different device.No patient complications were reported.
 
Event Description
It was reported that removal difficulty removal and shaft break occurred requiring additional intervention.The target lesion was located in the non-tortuous and moderately calcified proximal right coronary artery.A 5.00 x 32mm synergy megatron drug-eluting stent (des) was implanted successfully.During the removal of the delivery system, the balloon became stuck.Due to the catheter shaft stretching from pulling, the shaft broke proximal to the stent balloon but distal to the proximal shaft inside the patient.Part of the shaft was removed, but the balloon was still in the body.The detached portion was trapped in the guide with a trapper device and pulled out as a single system in a partially inflated state.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: synergy megatron mr us 5.00 x 32mm was returned for analysis.Visual, tactile, and microscopic analysis were performed on the device.Visual/tactile inspection and microscopic analysis found multiple kinks along the shaft.Visual/tactile inspection and microscopic analysis found that the shaft polymer extrusion was stretched and a break at the site of the wire exchange port, 121 cm from the hub.The rest of the shaft with stent and balloon was not returned.No other device issues were identified during returned product analysis.
 
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Brand Name
SYNERGY MEGATRON
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 Key18164914
MDR Text Key328446835
Report Number2124215-2023-60551
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729985808
UDI-Public08714729985808
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0031838065
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2023
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 Outcome(s) Required Intervention;
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