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

Lot Number	0031377454
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent moved on the balloon.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A us 4.00 x 32mm synergy xd drug-eluting stent was delivered with a guidezilla, however, the stent shifted on the balloon.The stent was removed, and the procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 32mm was returned for analysis.The device was received over a guidewire and inserted through the guidezilla guide catheter.A visual and tactile examination of the exposed section of hypotube (the section not inserted through the guidezilla) did not exhibit any kinks or damages.A visual examination of the distal extrusion identified no damages.A microscopic examination of the distal extrusion and balloon identified no damage.A microscopic examination of the crimped stent identified that the proximal section of the crimped stretched was pulled distally along the balloon.As a result, the crimped stent at its proximal end was bunched.As a result of the stent damage, it was not possible to retract that the damaged stent of the crimped stent back through the guidezilla catheter.The undamaged crimped stent outer diameter was measured, and the result was within maximum crimped stent profile measurement.
Event or Problem Description
It was reported that the stent moved on the balloon.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A us 4.00 x 32mm synergy xd drug-eluting stent was delivered with a guidezilla, however, the stent shifted on the balloon.The stent was removed, and the procedure was completed with a different device.There were no patient complications reported.

• 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 shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18120783
• Report Number: 2124215-2023-63436
• Device Sequence Number: 6988197
• Product Code: NIQ
• UDI-Device Identifier: 08714729981169
• UDI-Public: 08714729981169
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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): 01/08/2024

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: 03/20/2025
• Device Lot Number: 0031377454
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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