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

Model Number	H7493941820350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft break occurred.The target lesion was severely tortuous and moderately to severely calcified mid to distal right coronary artery.Pre-dilatation was performed and a 3.50 x 20mm synergy xd drug-eluting stent was advanced for treatment however, during delivery of the device to the lesion, the physician was pushing with a lot of force and the shaft of the stent broke near the hub.The physician pulled the stent shaft out and the procedure was completed with a new synergy stent.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: synergy xd 3.50 x 20mm stent delivery system was returned for analysis.A visual examination of the stent found no issues.There was no sign of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set between the proximal and distal markerbands.The stent outer diameter was measured and the result was within max crimped stent profile measurement the balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.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 and a break 22 cm distal to distal end of strain relief.A visual and tactile examination of the outer and mid-shaft section found no issues.
Event or Problem Description
It was reported that the shaft break occurred.The target lesion was severely tortuous and moderately to severely calcified mid to distal right coronary artery.Pre-dilatation was performed and a 3.50 x 20mm synergy xd drug-eluting stent was advanced for treatment however, during delivery of the device to the lesion, the physician was pushing with a lot of force and the shaft of the stent broke near the hub.The physician pulled the stent shaft out and the procedure was completed with a new synergy stent.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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15612391
• Report Number: 2124215-2022-41405
• Device Sequence Number: 20627643
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: 08714729981053
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• 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
• Report Date (Section B): 11/11/2022

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: 12/17/2023
• Device Model Number: H7493941820350
• Device Lot Number: 0028651014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 10/15/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• 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