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

Model Number	H7493941812220
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy xd mr us 2.25 x 12 mm stent delivery system was returned for analysis.A visual examination of the stent found that the stent was damaged with struts in the mid-section of the stent lifted.The undamaged crimped stent outer diameter was measured and the result was within maximum crimped stent profile measurement.Stent damage that was noted during analysis most likely occurred during handling of the device during preparation.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues with the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues with the extrusion shaft.A recommended 0.014 inch guidewire was tracked through the wire lumen of the device with no issues.Examination of the hub and strain relief via scope did not identify any issues.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on analysis completed on 27 nov 2020.A percutaneous coronary intervention was being performed on a lesion in the left anterior descending coronary artery.A 2.25 x 12mm synergy xd drug-eluting stent was attempted to be delivered over a non-boston scientific guidewire but the guidewire did not exit the guidewire port on the monorail portion.The procedure was successfully completed with a different device without issue or patient injury.However, returned device analysis revealed stent damage.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10960526
• Report Number: 2134265-2020-17102
• Device Sequence Number: 3189677
• Product Code: NIQ
• UDI-Device Identifier: 08714729980711
• UDI-Public: 08714729980711
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 12/07/2020

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: 05/27/2022
• Device Model Number: H7493941812220
• Device Lot Number: 0025569782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 12/07/2020
• Patient Sequence Number: 1