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

Model Number	H7493941812300
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event- used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 12mm synergy xd drug-eluting stent was advanced for treatment.The physician tried to cross the lesion, however, the stent struts were deformed.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status was stable.
Event or Problem Description
It was reported that stent damage occurred.A 3.00 x 12mm synergy xd drug-eluting stent was advanced for treatment.The physician tried to cross the lesion, however, the stent struts were deformed.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
B3.Date of event- used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: synergy xd mr us 3.00 x 12 mm stent delivery system was returned for analysis.A visual examination of the stent found proximal stent damage with struts pulled distally and lifted.The undamaged stent outer diameter was measured and the result was within maximum crimped stent profile measurement.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 distal tip damage.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of 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.No other issues were identified during analysis.

• 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: 12217073
• Report Number: 2134265-2021-09407
• Device Sequence Number: 19908989
• Product Code: NIQ
• UDI-Device Identifier: 08714729980957
• UDI-Public: 08714729980957
• Combination Product (Y/N): Y
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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: 11/23/2022
• Device Model Number: H7493941812300
• Device Lot Number: 0026455343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2021
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/23/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1