MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ?; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION

Model Number	H749390711900
Medical Device Problem Codes	Device-Device Incompatibility (2919); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device interaction occurred.A 99% stenosed target lesion was located in a non-tortuous and non-calcified coronary artery.The physician placed a ez 2.25mm-3.5mm 190cm us cv filterwire ez in the distal vein graft.The lesion was dilated with a balloon, and a 4.0 x 20 mm synergy drug-eluting stent was deployed without incident.During retrieval of the filterwire, the physician was unable to advance the retrieval sheath completely through the newly implanted stent.While attempting to retract the filter, it became caught on the distal end of the synergy stent.Upon successful removal of the filter, the distal end of the stent was noted to be deformed.A new guidewire was used to recross the damaged stent, followed by multiple balloon dilations.A 4.5 x 20 mm megatron stent was deployed within the deformed portion of the stent.The procedure was completed without complication.No patient harm or adverse effects were reported.

• Brand Name: FILTERWIRE EZ?
• Common Device Name: TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22359549
• Report Number: 2124215-2025-40013
• Device Sequence Number: 8621309
• Product Code: NFA
• UDI-Device Identifier: 08714729808800
• UDI-Public: (01)08714729808800(17)260705(10)34377083
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K061332
• 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): 06/30/2025

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: 07/05/2026
• Device Model Number: H749390711900
• Device Catalogue Number: H749390711900
• Device Lot Number: 0034377083
• 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: 06/02/2025
• Initial Report FDA Received Date: 06/30/2025
• Date Device Manufactured: 07/05/2024
• 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