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

Model Number	H7493941816250
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement and removal difficulty occurred.The physician mentioned a failed attempt at stenting the mid circumflex (cx) bifurcation due to challenging anatomy and difficulty crossing a previously placed stent in the ramus ostium which had stuck out into the left main artery and had protruded into the cx ostium.After placing an 8fr guide catheter, a 7fr guidezilla catheter-guide extension was used to deliver the 2.50 x 16mm synergy xd drug-eluting stent but was unable to cross the cx ostium due to a very acute 90-degree bend along with the protrusion of the previously placed stent.The physician attempted the inchworm technique to advance the guidezilla over the acute bend with very little success.The guidezilla had barely crossed or had "very minimum crossing" when the physician decided to deliver the stent and, while adjusting the stent placement, the 2 non-boston scientific guidewires moved from their original position and support was lost.During repositioning, a break was noted and the stent delivery system was withdrawn without the stent on the balloon.The guidewires were removed, but the radiopaque markers of the wires along with the dislodged stent remained in the cx.The physician attempted to entangle the broken wires and stent using 3-4 additional guidewires for removal but was unsuccessful.The physician advanced a 3.0 non-compliant balloon to cx to flatten and appose the dislodged stent and wire pieces to the vessel wall, and a new stent was advanced with no crossing difficulty and was deployed at the cx ostium.The procedure was completed with timi 3 flow.No patient complications were reported, and the patient was expected to fully recover.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21313180
• Report Number: 2124215-2025-04616
• Device Sequence Number: 18196235
• Product Code: NIQ
• UDI-Device Identifier: 08714729980803
• UDI-Public: 08714729980803
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P150003
• 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
• Report Date (Section B): 02/05/2025

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: 08/12/2026
• Device Model Number: H7493941816250
• Device Catalogue Number: H7493941816250
• Device Lot Number: 0034658635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 02/05/2025
• Date Device Manufactured: 08/12/2024
• 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