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

Model Number	H7493941824400
Medical Device Problem Codes	Device-Device Incompatibility (2919); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in a coronary artery.A 4.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, the stent detached from the balloon and stayed in the 6f guidezilla guide extension catheter when it was advanced.Both devices were removed from the patient successfully and the procedure was completed with another of the same device.No patient complications were reported.,.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 4.00 x 24mm stent delivery system was returned for analysis.Visual, tactile, microscopic, dimensional and device to device interaction analysis was performed on the device.Visual examination identified stent struts were pulled proximally and bunched at the distal section of the device.No issues identified with the hypotube shaft.The inner polymer extrusion was damaged, 5.5cm proximally from the tip of the device.The bumper tip showed signs of distal tip damage.Microscopic analysis of the stent struts identified stent struts pulled proximally in the distal section of the device and away from the distal markerband.No signs of stent movement on the proximal section of the stent however, stent struts were pulled proximally and bunched at the distal section of the device.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Dimensional testing revealed the undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.Device to device interaction revealed the device could be loaded and tracked over a 0.0140-inch guidewire with no issues.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.The 80% stenosed target lesion was located in a coronary artery.A 4.00 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, the stent detached from the balloon and stayed in the 6f guidezilla guide extension catheter when it was advanced.Both devices were removed from the patient successfully and the procedure was completed with another of the same device.No patient 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16787527
• Report Number: 2124215-2023-18732
• Device Sequence Number: 5695093
• Product Code: NIQ
• UDI-Device Identifier: 08714729981145
• UDI-Public: 08714729981145
• 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): 11/20/2023

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: 04/24/2024
• Device Model Number: H7493941824400
• Device Lot Number: 0029344854
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2022
• 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