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

Model Number	H7493941812350
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in distal right coronary artery (rca).A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.The stent was inserted through a previous placed mid rca stent, but would not cross the distal rca lesion.However, upon removal, the stent was damaged.The procedure was completed with another of the same device.There were no complications reported and the patient was in stable condition after the procedure.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in distal right coronary artery (rca).A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.The stent was inserted through a previous placed mid rca stent, but would not cross the distal rca lesion.However, upon removal, the stent was damaged.The procedure was completed with another of the same device.There were no complications reported and the patient was in stable condition after the procedure.It was further reported that the lesion was mildly tortuous and moderately calcified.The stent did not cross due to calcification and the stent struts were damaged.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in distal right coronary artery (rca).A 3.50 x 12mm synergy xd drug-eluting stent was advanced for treatment.The stent was inserted through a previous placed mid rca stent, but would not cross the distal rca lesion.However, upon removal, the stent was damaged.The procedure was completed with another of the same device.There were no complications reported and the patient was in stable condition after the procedure.It was further reported that the lesion was mildly tortuous and moderately calcified.The stent did not cross due to calcification and the stent struts were damaged.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.50 x 12mm stent delivery system was returned for analysis.A visual examination of the stent found evidence of damage with struts from the midsection to proximal end lifted and pulled distally.The undamaged crimped stent outer diameter was measured using a snap gauge 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 damage.A visual and tactile examination of the hypotube found multiple kinks.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.No other issues were identified during the product 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13008402
• Report Number: 2134265-2021-15813
• Device Sequence Number: 4848617
• Product Code: NIQ
• UDI-Device Identifier: 08714729981039
• UDI-Public: 08714729981039
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 01/18/2022

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: 01/19/2023
• Device Model Number: H7493941812350
• Device Lot Number: 0026713654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 12/15/2021; 01/10/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 12/30/2021; 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2021
• 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