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

Model Number	H7493941832250
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break and difficulty removal occurred.The target lesion was located in the moderately tortuous and severely calcified distal right coronary artery (rca).Following successful atherectomy and pre-dilatation, a 2.50 x 32mm synergy xd drug-eluting stent was selected for use.The device was difficult to deliver to the lesion through a non-boston scientific guide extension catheter due to tortuosity.Upon inflation and deployment, the inflation device lost pressure, and it was discovered that the stent shaft snapped.After several failed attempts to snare the device fragments, the broken distal shaft, balloon, and stent had to be secured up against the rca with an additional stent.The proximal portion of the device was removed.The procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break and difficulty removal occurred.The target lesion was located in the moderately tortuous and severely calcified distal right coronary artery (rca).Following successful atherectomy and pre-dilatation, a 2.50 x 32mm synergy xd drug-eluting stent was selected for use.The device was difficult to deliver to the lesion through a non-boston scientific guide extension catheter due to tortuosity.Upon inflation and deployment, the inflation device lost pressure, and it was discovered that the stent shaft snapped.After several failed attempts to snare the device fragments, the broken distal shaft, balloon, and stent had to be secured up against the rca with an additional stent.The proximal portion of the device was removed.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
This report was amended to update international medical device regulators forum (imdrf) codes.Incomplete coding of this event was identified during a retrospective review of complaints associated with capa-8580, which focused on identifying and remediating incomplete coding of events.Device analysis results device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history review: it was confirmed that this device met manufacturing specification prior to distribution and there are no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of adverse event related to procedure.This conclusion code is based on the event description.Upon inflation and deployment, the inflation device lost pressure, and it was discovered that the stent shaft snapped.It is most likely that procedural challenges, such as device interactions with other devices and interactions with potential challenging lesion anatomy likely contributed to the complaint event and after several failed attempts to snare the device fragments, the broken distal shaft, balloon, and stent had to be secured up against the rca with an additional stent.The reported shaft break is indicative of excessive force being applied to the delivery system during several attempts to deliver while encountering tortuosity.

• Brand Name: SYNERGY? XD
• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 20643681
• Report Number: 2124215-2024-68226
• Device Sequence Number: 7367303
• Product Code: NIQ
• UDI-Device Identifier: 08714729980841
• UDI-Public: 08714729980841
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 04/07/2026

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: 04/30/2026
• Device Model Number: H7493941832250
• Device Catalogue Number: H7493941832250
• Device Lot Number: 0034016544
• 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: 10/18/2024
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 04/07/2026
• Date Device Manufactured: 04/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDELINER GUIDE EXTENSION CATHETER; GUIDELINER GUIDE EXTENSION CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown