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

Model Number	H7493941816350
Medical Device Problem Codes	Inflation Problem (1310); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement and stent damage occurred.The target lesion was located in the moderately tortuous and severely calcified right coronary artery.The lesion was predilated and then a 3.50 x 16mm synergy xd drug-eluting stent was advanced for treatment.The balloon failed to inflate and the stent was dislodged and traveled onto the shaft of the catheter.The stent was totally disfigured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd 3.50 x 16 mm stent delivery system was returned for analysis.A visual examination of the stent found that the stent was damaged the whole length and moved proximally on the balloon.The crimped stent outer diameter (od) could not be measured due to the extent of the damage.The balloon cones were reviewed and appeared as if mid to distal balloon cone were exposed to positive pressure.The balloon body was covered in brownish medium resembling blood.There was no sign of damage noted on the balloon.A visual and microscopic examination of the bumper tip showed no signs of distal tip damage.A visual and tactile examination of the hypotube shaft found kinks along several locations of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues with the extrusion shaft.The device was placed in water-bath to soften the hardened media.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to the rated burst pressure to inflate the balloon and the balloon inflated with no issues.No leaks or damage to the balloon observed.The inflation device was verified for functionality to rated burst pressure before and after use with druck pressure tester.The mid to proximal region of the stent could not be expanded due to it being moved off the balloon.No other issues were identified during analysis.
Event or Problem Description
It was reported that stent dislodgement and stent damage occurred.The target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 3.50 x 16mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, the stent was dislodged and was totally disfigured.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported.It was further reported that the stent moved on the delivery system.The failure occurred during the second attempt in delivering the stent.The stent system was removed with the stent remained on the delivery sytem.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11801439
• Report Number: 2134265-2021-06014
• Device Sequence Number: 14443579
• Product Code: NIQ
• UDI-Device Identifier: 08714729981046
• UDI-Public: 08714729981046
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 01/28/2023
• Device Model Number: H7493941816350
• Device Lot Number: 0026798479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1