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

Model Number	H7493941832400
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified right coronary artery.A 4.00 x 32mm synergy xd drug eluting stent was advanced through a 6fr guidezilla guide extension catheter for treatment.However, upon advancing, resistance was felt at the collar of the guidezilla.After several attempts on pushing through the resistance, the physician noticed that the stent delivery system (sds) was bent and pushed one more time and the sds snapped in half distal to mid from the hub, closer to the middle shaft.The device was removed by pulling out from the body and the procedure was completed with a 4.0x28mm synergy xd drug-eluting stent.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 4.00 x 32mm stent delivery system was returned for analysis in 2 sections.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The crimped stent outer diameter was measured using 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 a shaft break at approximately 90.6cm distal to the distal strain relief, as well as multiple hypotube kinks at several locations along the hypotube shaft.A visual examination of the outer and inner lumen and mid-shaft section found no issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified right coronary artery.A 4.00 x 32mm synergy xd drug eluting stent was advanced through a 6fr guidezilla guide extension catheter for treatment.However, upon advancing, resistance was felt at the collar of the guidezilla.After several attempts on pushing through the resistance, the physician noticed that the stent delivery system (sds) was bent and pushed one more time and the sds snapped in half distal to mid from the hub, closer to the middle shaft.The device was removed by pulling out from the body and the procedure was completed with a 4.0x28mm synergy xd drug-eluting stent.There were no patient complications reported.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14936801
• Report Number: 2134265-2022-06972
• Device Sequence Number: 17322026
• Product Code: NIQ
• UDI-Device Identifier: 08714729981169
• UDI-Public: 08714729981169
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Date (Section B): 08/18/2022

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: 02/16/2024
• Device Model Number: H7493941832400
• Device Lot Number: 0028949480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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: Male