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

Model Number	H7493941812400
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.A 4.00 x 12mm synergy xd drug-eluting stent was advanced for treatment.The stent was inserted after properly preparing the lesion with an emerge balloon.However, after deploying the stent, the balloon was disconnected from the shaft and needed to be retrieved.A snare was used to remove the fractured device.An angiogram was performed to assess for issues and intravascular ultrasound (ivus) was used to check the stent.The procedure was then completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
Date of event: used the 1st day of the month of bsc aware date since event date was not provided.
Additional Manufacturer Narrative
B3: date of event: used the 1st day of the month of bsc aware date since event date was not provided.Device evaluated by mfr.: synergy xd mr us 4.00 x 12mm stent delivery system was returned for analysis without the stent.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture was within max crimped stent profile measurement.The balloon cones were reviewed and were noted to be in a deflated state.A visual and microscopic examination of the bumper tip showed no signs of tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination noted a break at 26cm distal to the distal end of the strain relief.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention.A 4.00 x 12mm synergy xd drug-eluting stent was advanced for treatment.The stent was inserted after properly preparing the lesion with an emerge balloon.However, after deploying the stent, the balloon was disconnected from the shaft and needed to be retrieved.A snare was used to remove the fractured device.An angiogram was performed to assess for issues and intravascular ultrasound (ivus) was used to check the stent.The procedure was then completed successfully.No patient complications were reported.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15826216
• Report Number: 2124215-2022-46065
• Device Sequence Number: 6156867
• Product Code: NIQ
• UDI-Device Identifier: 08714729981114
• UDI-Public: 08714729981114
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 01/31/2023

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: 12/08/2023
• Device Model Number: H7493941812400
• Device Lot Number: 0028597384
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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