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

Lot Number	0031016985
Medical Device Problem Codes	Device-Device Incompatibility (2919); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent became stuck in the guidezilla and came off the balloon.A 4.00 x 20mm synergy and 6f guidezilla ii were selected for percutaneous coronary intervention (pci).During insertion, the stent became stuck in the guidezilla causing it to bend and come off the balloon.The stent was removed with the guidezilla altogether.The procedure was completed with a different device.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual examination identified that the stent had been detached from the delivery system and damaged.Visual examination identified kinks along the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section identified a break.The bumper tip showed signs of damage.Microscopic analysis revealed that the stent was returned detached from the delivery system and bunched together.Bumper tip showed signs of tip damage with the distal section deformed.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.There was evidence of crimp markings visible on the balloon.Microscopic examination identified multiple kinks in various locations along the hypotube shaft.The device was returned with the stent detached.The stent damage was along the entire length of the stent and due to the extent of the damage a stent outer diameter (od) could not be obtained.The stent od at the time of manufacturing was within maximum crimped stent profile measurement as per specification.The device was successfully tracked through a recommended 0.014'' guidewire and 5f guide catheter with no issues.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that the stent became stuck in the guidezilla and came off the balloon.A 4.00 x 20mm synergy and 6f guidezilla ii were selected for percutaneous coronary intervention (pci).During insertion, the stent became stuck in the guidezilla causing it to bend and come off the balloon.The stent was removed with the guidezilla altogether.The procedure was completed with a different device.No complications were 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18295641
• Report Number: 2124215-2023-67156
• Device Sequence Number: 7316352
• Product Code: NIQ
• UDI-Device Identifier: 08714729981138
• UDI-Public: 08714729981138
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 02/06/2024

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: 01/30/2025
• Device Lot Number: 0031016985
• 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: 11/15/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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