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

Lot Number	0030178423
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event: used the first day of the aware date month as the event date as it was unknown.Device evaluated by mfr.: synergy xd mr us 4.00 x 20mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.Examination of the hypotube shaft identified multiple hypotube kinks along the shaft of the device.A visual and tactile examination of the outer and inner lumen and mid-shaft section found a break approximately 25cm from the distal tip at the guidewire exit port.No stent was returned for device analysis.Balloon cones were reviewed, and it appears to have been subjected to positive pressure, the balloon is not refolded and contrast in the balloon was observed.An examination of the proximal and distal markerband identified no issues.Bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.The patient was undergoing percutaneous coronary intervention.A 4.00 x 20mm synergy xd monorail drug-eluting stent was advanced for treatment.However, while crossing the lesion, the stent shaft fractured at the guidewire exit port.The device was removed with a snare.A new stent was used to complete the procedure successfully.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event: used the first day of the aware date month as the event date as it was unknown.
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.The patient was undergoing percutaneous coronary intervention.A 4.00 x 20mm synergy xd monorail drug-eluting stent was advanced for treatment.However, while crossing the lesion, the stent shaft fractured at the guidewire exit port.The device was removed with a snare.A new stent was used to complete the procedure 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: 19243506
• Report Number: 2124215-2024-23100
• Device Sequence Number: 12601537
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: 08714729981138
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 09/13/2024
• Device Lot Number: 0030178423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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 Age: 87 YR
• Patient Sex: Male