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

Model Number	H7493941808270
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with acute coronary syndrome and underwent percutaneous coronary intervention.The 80% stenosed target lesion was located in the severely tortuous and mildly calcified mid obtuse marginal artery.After obtaining vascular access via the right radial artery, a 6f long guidezilla ii guide-extension catheter was advanced.A 2.75 x 8mm synergy xd drug-eluting stent was introduced but had difficulty advancing in the guide-extension catheter.Furthermore, difficult anatomy was noted as the right subclavian artery and obtuse marginal artery were very tortuous.Subsequently, the device failed to cross the lesion and got stuck on the 014 guidewire.The entire system was pulled out as a unit and the procedure was completed with plain old balloon angioplasty.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd 2.75 x 8mm stent delivery system was returned for analysis.Device returned with 0.014in guide wire attached.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 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 hypotube kinks at several locations along the hypotube shaft as well as a hypotube break 96cm proximal to distal end of distal tip.A visual examination of the outer and inner lumen and mid-shaft section found no issues along the shaft polymer extrusion.
Event or Problem Description
It was reported that device entrapment occurred.The patient presented with acute coronary syndrome and underwent percutaneous coronary intervention.The 80% stenosed target lesion was located in the severely tortuous and mildly calcified mid obtuse marginal artery.After obtaining vascular access via the right radial artery, a 6f long guidezilla ii guide-extension catheter was advanced.A 2.75 x 8mm synergy xd drug-eluting stent was introduced but had difficulty advancing in the guide-extension catheter.Furthermore, difficult anatomy was noted as the right subclavian artery and obtuse marginal artery were very tortuous.Subsequently, the device failed to cross the lesion and got stuck on the 014 guidewire.The entire system was pulled out as a unit and the procedure was completed with plain old balloon angioplasty.No patient complications were 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: 15915488
• Report Number: 2124215-2022-49927
• Device Sequence Number: 12398065
• Product Code: NIQ
• UDI-Device Identifier: 08714729980865
• UDI-Public: 08714729980865
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 01/27/2023

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: 01/13/2023
• Device Model Number: H7493941808270
• Device Lot Number: 0026654131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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