MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY MEGATRON; CORONARY DRUG-ELUTING STENT

Lot Number	0031838065
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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.

• Brand Name: SYNERGY MEGATRON
• Common Device Name: 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 Key: 18164914
• Report Number: 2124215-2023-60551
• Device Sequence Number: 6646666
• Product Code: NIQ
• UDI-Device Identifier: 08714729985808
• UDI-Public: 08714729985808
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2024
• Device Lot Number: 0031838065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown