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

Lot Number	0033279751
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent moved on balloon occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A comet wire was introduced for dfr of the lad.Following pre-dilation with a 2.5mm emerge balloon, the 3.00 x 16 mm synergy xd drug eluting stent was advanced over the comet wire.The device was difficult to advance and when it was being removed, the stent started to come off the balloon.Everything was removed and the procedure was completed with a new wire and stent.There were no patient complications.
Additional Manufacturer Narrative
The device was returned and evaluated by manufacturer.No issues identified with the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.Examination of the crimped stent via scope found evidence of stent damage with the struts being lifted at the distal section.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A microscopic inspection of the outer and inner lumen noted that the inner was bunched.The bumper tip was very damaged with a portion of it missing.The undamaged crimped stent od (outer diameter) was measured within max crimped stent profile measurement.The device could not be loaded and tracked over a 0.014-inch guidewire.
Event or Problem Description
It was reported that stent moved on balloon occurred.The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery (lad).A comet wire was introduced for dfr of the lad.Following pre-dilation with a 2.5mm emerge balloon, the 3.00 x 16 mm synergy xd drug eluting stent was advanced over the comet wire.The device was difficult to advance and when it was being removed, the stent started to come off the balloon.Everything was removed and the procedure was completed with a new wire and stent.There were no patient complications.

• 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
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19411445
• Report Number: 2124215-2024-30400
• Device Sequence Number: 8747311
• Product Code: NIQ
• UDI-Device Identifier: 08714729980964
• UDI-Public: 08714729980964
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 06/21/2024

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: 01/09/2026
• Device Lot Number: 0033279751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: COMET WIRE; COMET WIRE; GUIDE CATHETER - MACH 1; GUIDE CATHETER - MACH 1
• Patient Sex: Unknown