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

Model Number	H7493941820350
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation failure occurred and removal difficulties were encountered.A 3.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent balloon could not be retracted normally inside the guide catheter and it was difficult to deflate.The procedure was completed with this device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: synergy xd mr us 3.50 x 20mm stent delivery system was returned for analysis.The device was returned without the stent as it was implanted at the lesion site.The balloon cones were reviewed, and signs of positive pressure applied to them were noted as the balloon folds were noted to be relaxed and crimp stent markings were visible on the balloon body.The distal balloon cone was noted to be bunched.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 along the length of the hypotube shaft.A visual and tactile examination of the outer and mid-shaft section found an inner shaft bunching at 6.7 cm proximal to distal tip as well as a shaft polymer extrusion stretch measured at 24 cm from distal tip.Device to device interaction: a test guidewire was introduced through tip but could not be tracked due to the inner shaft bunching.Therefore, the device could not be advanced over the wire and through a test guidecatheter to verify the inability to be removed through a guide allegation.An encore inflation device was attached the balloon was inflated without issues.A vacuum was pulled using the encore device and the balloon delated fully in 21s.No other issues noted with device.
Event or Problem Description
It was reported that deflation failure occurred and removal difficulties were encountered.A 3.50 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noted that the stent balloon could not be retracted normally inside the guide catheter and it was difficult to deflate.The procedure was completed with this device.There were no patient complications nor injuries 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13870718
• Report Number: 2134265-2022-03275
• Device Sequence Number: 20000049
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: 08714729981053
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 10/18/2023
• Device Model Number: H7493941820350
• Device Lot Number: 0028300128
• 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: 03/16/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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