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

Model Number	H7493941812300
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified diagonal branch into the left anterior descending artery.A 3.00 x 12mm synergy xd drug eluting stent was advanced for treatment but it could not advance through the lesion.However, when the stent was pulled back, the stent came off the balloon.After noticing the stent was off the balloon a small 1.2mm emerge balloon was advanced into the undeployed stent which was half way into the guide.The emerge balloon was inflated slightly to capture the stent into the guide catheter.The whole system was removed as one unit and everything was withdrawn.Then the procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that stent dislodgement occurred.The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified diagonal branch into the left anterior descending artery.A 3.00 x 12mm synergy xd drug eluting stent was advanced for treatment but it could not advance through the lesion.However, when the stent was pulled back, the stent came off the balloon.After noticing the stent was off the balloon we used a small emerge balloon 1.2mm to go into the undeployed stent which was half way into the guide and inflated it slightly to capture the stent in the guide.They then removed the whole system as one unit and everything came out.Then the procedure was completed with a different device.There were no patient complications reported.It was further reported that the lesion was 40% stenosed after preparation treatment and the stent tracked well into the lesion.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 3.00 x 12mm stent delivery system was returned for analysis.The device was returned without the stent attached.A review of the manufacturing stent profile data was performed and the stent outer diameter at the time of manufacture 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 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 no issues along the shaft.No other issues noted with device.
Event or Problem Description
It was reported that stent dislodgement occurred.The 100% stenosed target lesion was located in the moderately tortuous and mildly calcified diagonal branch into the left anterior descending artery.A 3.00 x 12mm synergy xd drug eluting stent was advanced for treatment but it could not advance through the lesion.However, when the stent was pulled back, the stent came off the balloon.After noticing the stent was off the balloon a small 1.2mm emerge balloon was advanced into the undeployed stent which was half way into the guide.The emerge balloon was inflated slightly to capture the stent into the guide catheter.The whole system was removed as one unit and everything was withdrawn.Then the procedure was completed with a different device.There were no patient complications reported.It was further reported that the lesion was 40% stenosed after preparation treatment and the stent tracked well into the lesion.

• 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: 13359569
• Report Number: 2134265-2022-00719
• Device Sequence Number: 4646449
• Product Code: NIQ
• UDI-Device Identifier: 08714729980957
• UDI-Public: 08714729980957
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2022

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: 09/09/2023
• Device Model Number: H7493941812300
• Device Lot Number: 0028083611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 02/22/2022; 03/11/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/03/2022; 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown