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

Model Number	H7493941824300
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 24mm synergy xd drug eluting stent was advanced for treatment.However, the stent delivery system broke during insertion.The device was removed intact over the wire and a different device was used to complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 24mm synergy xd drug eluting stent was advanced for treatment.However, the stent delivery system broke during insertion.The device was removed intact over the wire and a different device was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the synergy xd mr us 3.00 x 24mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found damage.Stent struts towards the distal end of the stent were stretched and pulled distally, beyond the distal markerband.The undamaged stent outer diameter was measured using snap gauge and the result within max crimped stent profile measurement.The balloon cones were reviewed, and there were no signs of positive pressure applied.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube identified that the hypotube was severely kinked at various locations along its length.No breaks were present.A visual and tactile examination of the outer and mid-shaft section found no issues.No breaks were present.
Additional Manufacturer Narrative
F10 - device codes: removed code for break and added failure to advance.Device evaluated by mfr.: the synergy xd mr us 3.00 x 24mm stent delivery system (sds) was returned for analysis.A visual examination of the stent found damage.Stent struts towards the distal end of the stent were stretched and pulled distally, beyond the distal markerband.The undamaged stent outer diameter was measured using snap gauge and the result within max crimped stent profile measurement.The balloon cones were reviewed, and there were no signs of positive pressure applied.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube identified that the hypotube was severely kinked at various locations along its length.No breaks were present.A visual and tactile examination of the outer and mid-shaft section found no issues.No breaks were present.
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 24mm synergy xd drug eluting stent was advanced for treatment.However, the stent delivery system broke during insertion.The device was removed intact over the wire and a different device was used to complete the procedure.No patient complications were reported.It was further reported that the target lesion was 70% stenosed and was located in the moderately tortuous and severely calcified left anterior descending artery (lad).Additionally, the returned device was a no-cross stent as opposed to a broken stent.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16249983
• Report Number: 2124215-2023-03186
• Device Sequence Number: 15066263
• Product Code: NIQ
• UDI-Device Identifier: 08714729980988
• UDI-Public: 08714729980988
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 05/05/2023

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: 04/25/2024
• Device Model Number: H7493941824300
• Device Lot Number: 0029375321
• 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: 01/18/2023
• Supplement Date Received by Manufacturer: 03/28/2023; 04/26/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/30/2023; 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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
• Patient Sex: Unknown