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

Model Number	7577
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the filter basket separated from the wire and was stented inside the patient's body.The target lesion was located in the saphenous vein graft (svg) to distal right coronary artery.During a percutaneous coronary intervention procedure a 190cm filterwire ez was prepped and delivered into the target lesion, two synergy stents were deployed in the distal and proximal segments of the svg.Subsequently, the stent delivery balloon system came in contact with the proximal collar of the filterwire upon positioning of the distal stent.The retrieval sheath was then inserted into the svg after both stents were placed; however, as the sheath was being delivered, the guide catheter disengaged from the svg and the filter basket was withdrawn, unsheathed, through both stents.Consequently, the filter basket separated from the filterwire and the remaining portion of the device and sheath were then removed from the patient's body leaving the filter basket at the ostium of the svg.Snaring was attempted to retrieve the basket; however, the basket was driven through the proximal and distal stents.The basket was then deliberately pushed beyond the distal stent where a third stent was deployed and used to press the basket into the svg wall where it remained.The procedure was completed with the device.The patient tolerated the entire event without complications and left the facility immediately post procedure.
Event or Problem Description
It was reported that the filter basket separated from the wire and was stented inside the patient's body.The target lesion was located in the saphenous vein graft (svg) to distal right coronary artery.During a percutaneous coronary intervention procedure a 190cm filterwire ez was prepped and delivered into the target lesion, two synergy stents were deployed in the distal and proximal segments of the svg.Subsequently, the stent delivery balloon system came in contact with the proximal collar of the filterwire upon positioning of the distal stent.The retrieval sheath was then inserted into the svg after both stents were placed; however, as the sheath was being delivered, the guide catheter disengaged from the svg and the filter basket was withdrawn, unsheathed, through both stents.Consequently, the filter basket separated from the filterwire and the remaining portion of the device and sheath were then removed from the patient's body leaving the filter basket at the ostium of the svg.Snaring was attempted to retrieve the basket; however, the basket was driven through the proximal and distal stents.The basket was then deliberately pushed beyond the distal stent where a third stent was deployed and used to press the basket into the svg wall where it remained.The procedure was completed with the device.The patient tolerated the entire event without complications and left the facility immediately post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The sheath slit was returned split.The protective wire returned completely out of the sheath slit.Additionally, the spring tip was observed to be broken and the most distal section was not returned.The outer diameter (od) dimensions were found within specification.Sheathing and unsheathing test was performed and the filter bag was unsuccessfully retracted or deployed due to the protection wire being exposed from the sheath slit.Inspection of the remainder of the device presented no other damages or irregularities.

• Brand Name: FILTERWIRE EZ
• Common Device Name: TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8313599
• Report Number: 2134265-2019-00830
• Device Sequence Number: 2126326
• Product Code: NFA
• UDI-Device Identifier: 08714729808800
• UDI-Public: 08714729808800
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K061332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2020
• Device Model Number: 7577
• Device Catalogue Number: 7577
• Device Lot Number: 0021641732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Initial Date Received by Manufacturer: 01/16/2019
• Supplement Date Received by Manufacturer: 03/02/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR