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

Lot Number	0032513922
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and shaft break occurred resulting in patient complications.The 95% stenosed target lesion was located in the moderately tortuous and moderately calcified saphenous vein graft to the obtuse marginal branch.After pre-dilatation of the vein graft, a 5.00 x 24 mm synergy megatron drug-eluting stent was advanced for treatment.During the initial inflation at 14 atmospheres, the stent was successfully deployed but the stent balloon ruptured.During removal of the balloon, approximately 20 cm of the distal portion of the stent delivery system broke and separated.The physician then introduced a second non-boston scientific (bsc) guidewire along with a 3.00 x 12 mm nc emerge balloon catheter and was able to inflate the balloon enough to pin the broken shaft and remove everything from the patient.Shortly afterward, the patient may have suffered a stroke.The patient has since recovered with no further issues and is currently stable.

• 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: 19988507
• Report Number: 2124215-2024-48968
• Device Sequence Number: 7075864
• Product Code: NIQ
• UDI-Device Identifier: 08714729985723
• UDI-Public: 08714729985723
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2024

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: 09/11/2025
• Device Lot Number: 0032513922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/14/2024
• Date Device Manufactured: 09/12/2023
• 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