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

Model Number	H7493941820500
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.A 5.00 x 20mm synergy drug-eluting stent was selected for saphenous vein graft (svg) percutaneous coronary interventions (pci) procedure.During the procedure, the balloon inflated and stent fully deployed at 22 atmospheres.The balloon became stuck on the guide catheter within the svg and when the physician attempted to remove it, the catheter shaft fractured at the guidewire exit port.The device was removed and the procedure completed successfully with this device.There was no patient complications; the patient status was stable and they were discharged post procedure.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.A 5.00 x 20mm synergy drug-eluting stent was selected for saphenous vein graft (svg) percutaneous coronary interventions (pci) procedure.During the procedure, the balloon inflated and stent fully deployed at 22 atmospheres.The balloon became stuck on the guide catheter within the svg and when the physician attempted to remove it, the catheter shaft fractured at the guidewire exit port.The device was removed and the procedure completed successfully with this device.There was no patient complications; the patient status was stable and they were discharged post procedure.
Additional Manufacturer Narrative
The synergy xd mr us 5.00 x 20mm stent delivery system (sds) was returned for analysis on the customer guidewire and with distal shaft through a customer 13 cm introducer sheath.The device was returned without the stent as it was implanted at the lesion site.The balloon cones were reviewed, and signs of positive pressure applied to them were noted as the balloon folds were noted to be relaxed and crimp stent markings were visible on the balloon body.The distal balloon cone appeared bunched distally.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found a break at the exchange port region of the shaft polymer extrusion measured at 28 cm proximal to distal tip.No other issues noted with device.

• 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: 14875422
• Report Number: 2134265-2022-07515
• Device Sequence Number: 5690095
• Product Code: NIQ
• UDI-Device Identifier: 08714729981268
• UDI-Public: 08714729981268
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2023
• Device Model Number: H7493941820500
• Device Lot Number: 0027754769
• 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: 06/13/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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
• Patient Sex: Unknown