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

Model Number	H7493941812500
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.After a 5.00x12mm synergy xd drug-eluting stent was deployed, the stent delivery system (sds) balloon would not come through the distal end of the guide catheter even after multiple attempts.When the device was pulled harder, the shaft broke at the distal end near the balloon.The physician used a guidezilla to engulf the balloon successfully.The guidezilla, sds, and guide were then removed simultaneously.The sds balloon was removed fully deflated.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
H6 device codes: corrected.The synergy xd mr us 5.00 x 12mm 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.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 complete hypotube break was noted at 24 cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen identified no issues.
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.After a 5.00x12mm synergy xd drug-eluting stent was deployed, the stent delivery system (sds) balloon would not come through the distal end of the guide catheter even after multiple attempts.When the device was pulled harder, the shaft broke at the distal end near the balloon.The physician used a guidezilla to engulf the balloon successfully.The guidezilla, sds, and guide were then removed simultaneously.The sds balloon was removed fully deflated.The procedure was completed with a different device.No patient complications were reported.It was further reported that a 0.014 guidewire and a 6f guide catheter were used and the lesion was prepared with a compliant balloon.No resistance was encountered while advancing the device over the wire and in the guide catheter.There was no significant bend in the lesion.Before the stent balloon was pulled, the balloon was deflated for 15 seconds and fluoroscopy confirmed there was no contrast in the balloon.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13500624
• Report Number: 2134265-2022-01403
• Device Sequence Number: 17079782
• Product Code: NIQ
• UDI-Device Identifier: 08714729981244
• UDI-Public: 08714729981244
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 03/29/2022

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: 05/10/2023
• Device Model Number: H7493941812500
• Device Lot Number: 0027392383
• 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: 02/02/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2021
• 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: Other
• Patient Sex: Unknown