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

Model Number	H7493941832250
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred, requiring additional intervention.The patient presented with disease throughout the whole vessel via angiography and was undergoing percutaneous coronary intervention.The target lesion was located in the moderately calcified right coronary artery.A 2.50 x 32mm synergy xd drug-eluting stent was advanced for treatment.The first stent placement was successful with the use of a non-boston scientific (bsc) guide extension catheter to aid in deliverability and support.However, when the physician attempted to advance the second stent in between a non-boston scientific (bsc) guide extension catheter and the first stent, the stent got caught on the proximal edge of the first stent and possibly on calcium and resistance was encountered.Consequently, the balloon catheter broke off due to the resistance inside the vessel, leaving the balloon and stent separated from the delivery system.The physician was able to retrieve the stent and the distal balloon catheter with a snare.A new stent was placed, and the procedure was completed successfully.No patient complications were reported.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20800862
• Report Number: 2124215-2024-72698
• Device Sequence Number: 17833694
• Product Code: NIQ
• UDI-Device Identifier: 08714729980841
• UDI-Public: 08714729980841
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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): 11/27/2024

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: 01/28/2026
• Device Model Number: H7493941832250
• Device Catalogue Number: H7493941832250
• Device Lot Number: 0033464811
• 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: 11/07/2024
• Initial Report FDA Received Date: 11/27/2024
• Date Device Manufactured: 01/29/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown