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

Model Number	H7493941820350
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shaft break occurred requiring additional intervention.The 80-90% stenosed target lesion was located in the non-tortuous and non-calcified left anterior descending artery (lad).A 3.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, when the stent was tracking through the guide catheter, resistance was noted and the physician felt the monorail shaft shift.Fluoroscopy was performed and it was noted that the shaft had broken inside the guide catheter.A balloon was inserted into the guide catheter past the stent and was inflated; eventually, the device and guide were removed from the patient's body successfully.The physician then re-wired the lad.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.50 x 20mm stent delivery system was returned for analysis.Examination of the crimped stent via scope found evidence of damage with proximal stent struts lifted.The undamaged crimped stent outer diameter was measured and the result was 0.0415inch and this is within max crimped stent profile measurement.The balloon cones were reviewed via scope, and no issues were noted.The balloon wings were tightly wrapped and evenly folded.The balloon had not been subjected to positive pressure.A visual and microscopic examination of the bumper tip showed a damaged tip.A visual and tactile examination of the hypotube identified a break on the hypotube shaft located approximately 43.5cm distal to the distal end of strain relief as well as multiple kinks.The shaft polymer extrusion including the distal and mid-shaft sections were examined via scope and tactile examination.No issues were noted.The device could not be loaded on a 0.014inch test guidewire due to the damaged noted to the tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a shaft break occurred requiring additional intervention.The 80-90% stenosed target lesion was located in the non-tortuous and non-calcified left anterior descending artery (lad).A 3.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, when the stent was tracking through the guide catheter, resistance was noted and the physician felt the monorail shaft shift.Fluoroscopy was performed and it was noted that the shaft had broken inside the guide catheter.A balloon was inserted into the guide catheter past the stent and was inflated; eventually, the device and guide were removed from the patient's body successfully.The physician then re-wired the lad.The procedure was completed with another of the same device.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: 15752643
• Report Number: 2124215-2022-45262
• Device Sequence Number: 2907638
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: 08714729981053
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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): 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2024
• Device Model Number: H7493941820350
• Device Lot Number: 0029778562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male