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

Model Number	H7493941820300
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred requiring additional intervention.The 70% stenosed target lesion was moderately tortuous and moderately calcified.A 3.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, a resistance was felt when attempting to pass the stent through lesion, the stent was dislodged from the balloon at the proximal vessel.The physician did not attempt to remove the dislodged stent.The detached component was left in the patient to avoid the risk of embolization of the device.The stent was then dilated with small balloons to deploy the stent and the procedure was completed successfully.No patient complications were reported, and the patient was in stable condition.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.00 x 20mm stent delivery system was returned for analysis.The device was returned without the stent attached.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 there were no signs of positive pressure applied.Crimp markings were visible.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and mid-shaft section found no issues along the shaft.No other issues noted with device.
Event or Problem Description
It was reported that stent dislodgement occurred requiring additional intervention.The 70% stenosed target lesion was moderately tortuous and moderately calcified.A 3.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, a resistance was felt when attempting to pass the stent through lesion, the stent was dislodged from the balloon at the proximal vessel.The physician did not attempt to remove the dislodged stent.The detached component was left in the patient to avoid the risk of embolization of the device.The stent was then dilated with small balloons to deploy the stent and the procedure was completed successfully.No patient complications were reported, and the patient was in stable condition.

• 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: 15826498
• Report Number: 2124215-2022-46620
• Device Sequence Number: 20372693
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: 08714729980971
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/20/2023

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: 12/16/2023
• Device Model Number: H7493941820300
• Device Lot Number: 0028641314
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• 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