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

Lot Number	0033508276
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in left anterior descending artery.A 3.50 x 12mm synergy xd drug-eluting stent was implanted.However, upon removal of the stent delivery system, the mid shaft fractured into two inside the patient.The fractured portion was pulled back into the guide and was completely removed from the patient's body together with the guide.The procedure was completed, and no patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in left anterior descending artery.A 3.50 x 12mm synergy xd drug-eluting stent was implanted.However, upon removal of the stent delivery system, the mid shaft fractured into two inside the patient.The fractured portion was pulled back into the guide and was completely removed from the patient's body together with the guide.The procedure was completed, and no patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 3.50 x 12mm was returned for analysis.A visual and tactile inspection identified no issues with the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion identified multiple kinks and the distal shaft was stretched.There was a break in the distal shaft 4.5cm distal to the guidewire exchange port.There was no stent attached to the balloon as it was implanted.Bumper tip showed no signs of distal tip damage.

• 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: 19278915
• Report Number: 2124215-2024-28336
• Device Sequence Number: 7649006
• Product Code: NIQ
• UDI-Device Identifier: 08714729981039
• UDI-Public: 08714729981039
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/24/2024

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: 02/05/2026
• Device Lot Number: 0033508276
• 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: 04/24/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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