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

Lot Number	0029810710
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in a moderately tortuous and severely calcified coronary artery.A 2.50 x 24mm synergy xd drug-eluting stent was advanced for treatment but it could not advance across the lesion.An additional balloon was used to predilate the lesion again.A longer stent was inserted into the lesion, but it also could not advance.A guidezilla catheter was then used to facilitate passage through the vessel.The stent was re-inserted and successfully crossed the lesion.However, upon attempting to inflate the balloon to expand the stent, the indeflator did not register any pressure and the stent could not be deployed.When the stent was being removed, it detached within the hemostasis valve, about 1/3 from the distal end of the catheter.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.50 x 24mm stent delivery system (sds) was returned for analysis.A visual and tactile examination revealed that the hypotube identified multiple kinks along the hypotube.A visual and tactile examination of the distal shaft and mid-shaft section found a break.The distal section of the device was broken into 3 sections.The midshaft was stretched and broken at the wire port bond.The distal section of the device was detached, 13.4cm in length from the bumper tip to the polymer extrusion.At the laser cut region a break was identified 109cm distal from the distal end of the strain relief.Microscopic analysis revealed that the stent was found to be damaged, with struts flattened at the distal end of the stent.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No signs of movement, stent was set between the proximal and distal markerbands.Examination of the distal shaft and mid-shaft section via scope identified damage on the distal shaft.Further examination found that the inner lumen along with the distal markerband to be flattened.Bumper tip showed no signs of distal tip damage.No issues were noted with the proximal markerband however, the distal markerband was flattened.The crimped stent outer diameter was measured by snap gauge and the result was within max crimped stent profile measurement.
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in a moderately tortuous and severely calcified coronary artery.A 2.50 x 24mm synergy xd drug-eluting stent was advanced for treatment but it could not advance across the lesion.An additional balloon was used to predilate the lesion again.A longer stent was inserted into the lesion, but it also could not advance.A guidezilla catheter was then used to facilitate passage through the vessel.The stent was re-inserted and successfully crossed the lesion.However, upon attempting to inflate the balloon to expand the stent, the indeflator did not register any pressure and the stent could not be deployed.When the stent was being removed, it detached within the hemostasis valve, about 1/3 from the distal end of the catheter.The procedure was completed with a different device.There were no patient complications reported.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19428354
• Report Number: 2124215-2024-32958
• Device Sequence Number: 12749434
• Product Code: NIQ
• UDI-Device Identifier: 08714729980827
• UDI-Public: 08714729980827
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/25/2024

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: 07/06/2024
• Device Lot Number: 0029810710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 05/30/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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: Female