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

Model Number	H7493941848350
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 3.50 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the device failed to cross the lesion and the shaft broke.The device was removed and the procedure was completed with a non-boston scientific device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was not returned for analysis, however, a photo of the device was received illustrating the reported event as shaft break as well as unreported hypotube kinks.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the photo provided by the site confirms the alleged issue as the hypotube shaft of the device is noted to be broken in 2 pieces with one end of the break shown at the top of the picture and the second section of the break shown at the bottom of the picture.Additionally shaft kinks are also noted near the bottom broken section of the device.
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 3.50 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the device failed to cross the lesion and the shaft broke.The device was removed and the procedure was completed with a non-boston scientific device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
A review of the photo provided by the site confirms the alleged issue as the hypotube shaft of the device is noted to be broken in 2 pieces with one end of the break shown at the top of the picture and the second section of the break shown at the bottom of the picture.Additionally shaft kinks are also noted near the bottom broken section of the device.The synergy xd mr us 3.50 x 48mm stent delivery system (sds) 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 od (outer diameter) was measured 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 26cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and mid-shaft section found no issues.No other issues noted with device.
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 3.50 x 48mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the device failed to cross the lesion and the shaft broke.The device was removed and the procedure was completed with a non-boston scientific device.There were no patient complications nor injuries reported.It was further reported that the break occurred outside the tuohy.

• 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: 14583800
• Report Number: 2134265-2022-05673
• Device Sequence Number: 1996456
• Product Code: NIQ
• UDI-Device Identifier: 08714729985235
• UDI-Public: 08714729985235
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 06/24/2022

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: 02/03/2024
• Device Model Number: H7493941848350
• Device Lot Number: 0028859388
• 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: 05/10/2022
• Supplement Date Received by Manufacturer: 06/02/2022; 06/06/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 06/06/2022; 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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