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

Model Number	H7493941838350
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a mildly tortuous and moderately calcified coronary artery.Following pre-dilatation, a 3.50 x 38mm synergy xd drug eluting stent was advanced for treatment.However, advancing difficulties were encountered.During removal of the device, the stent came off the stent delivery system inside the guide.The physician removed the guide and stent as a unit.The procedure was completed with a new synergy stent.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.50 x 38mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found proximal stent damage with struts slightly expanded.The undamaged stent outer diameter was measured using snap gauge and the result was within max crimped stent profile measurement.The balloon cones were reviewed, and there were no signs of positive pressure applied.Crimp markings were visible.A visual and microscopic examination of the bumper tip showed 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 inner shaft damage.Device could not be tracked on a 0.0140 inch test guidewire due to the extent of the inner damage.No other issues noted with device.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in a mildly tortuous and moderately calcified coronary artery.Following pre-dilatation, a 3.50 x 38mm synergy xd drug eluting stent was advanced for treatment.However, advancing difficulties were encountered.During removal of the device, the stent came off the stent delivery system inside the guide.The physician removed the guide and stent as a unit.The procedure was completed with a new synergy stent.There were no patient complications reported.It was further reported that there was resistance in the lesion while advancing.Additionally, the stent came off the shaft due to resistance.

• 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: 14088755
• Report Number: 2134265-2022-04265
• Device Sequence Number: 5543077
• Product Code: NIQ
• UDI-Device Identifier: 08714729981091
• UDI-Public: 08714729981091
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 08/05/2023
• Device Model Number: H7493941838350
• Device Lot Number: 0027866989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• 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