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

Model Number	H7493941828350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient underwent a percutaneous coronary intervention.The 75% stenosed complex target lesion was located in the moderately tortuous and severely calcified circumflex artery.A 3.50 x 28mm synergy xd stent was advanced for treatment and was successfully implanted.However, when attempting to remove the stent delivery system, the shaft fractured.It had to be removed inside the guide catheter.Everything was successfully removed from the body without complications.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the synergy xd mr us 3.50 x 28mm stent delivery system (sds) was returned for analysis.Visual and tactile inspection revealed a shaft break was noted at the site of the guidewire port.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic analysis showed no stent was attached to the device as it was successfully implanted.Balloon profile: balloon cones were reviewed and was subjected to positive pressure.Bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that shaft break occurred.The patient underwent a percutaneous coronary intervention.The 75% stenosed complex target lesion was located in the moderately tortuous and severely calcified circumflex artery.A 3.50 x 28mm synergy xd stent was advanced for treatment and was successfully implanted.However, when attempting to remove the stent delivery system, the shaft fractured.It had to be removed inside the guide catheter.Everything was successfully removed from the body without complications.No patient complications were reported and the patient status was stable.

• 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: 17174059
• Report Number: 2124215-2023-32160
• Device Sequence Number: 20698466
• Product Code: NIQ
• UDI-Device Identifier: 08714729981077
• UDI-Public: 08714729981077
• 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: 2023
• 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): 08/25/2023

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: 07/03/2024
• Device Model Number: H7493941828350
• Device Lot Number: 0029737067
• 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: 06/09/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2022
• 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
• Patient Sex: Unknown