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

Lot Number	0031931279
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent moved on the balloon and removal difficulty occurred.The target lesion was located in the non-tortuous and mild to moderately calcified left main artery.A 3.50 x 20mm synergy xd drug-eluting was advanced to treat the lesion.The stent balloon was inflated and deflated and re-inflated again.Upon removal of the stent deployment balloon, resistance was felt as the deployment device was about to exit the guide catheter.The device was removed with some force, and upon removal, it was noted that the stent did not deploy in the left main artery.It was observed that the stent had moved on the balloon and was damaged.The procedure was completed with another synergy xd drug-eluting stent.No patient complications were reported.
Event or Problem Description
It was reported that the stent moved on the balloon and removal difficulty occurred.The target lesion was located in the non-tortuous and mild to moderately calcified left main artery.A 3.50 x 20mm synergy xd drug-eluting was advanced to treat the lesion.The stent balloon was inflated and deflated and re-inflated again.Upon removal of the stent deployment balloon, resistance was felt as the deployment device was about to exit the guide catheter.The device was removed with some force, and upon removal, it was noted that the stent did not deploy in the left main artery.It was observed that the stent had moved on the balloon and was damaged.The procedure was completed with another synergy xd drug-eluting stent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: product analysis: synergy xd mr us 3.50 x 20mm, catheter was returned for analysis.A visual, tactile, microscopic and functional testing was performed.A visual and tactile examination identified no kinks or damages.A visual and tactile examination of the distal extrusion identified no damages.A visual examination of the balloon identified that the balloon had been inflated and there was a significant build-up of solidified contrast media inside the balloon.No stent was received with the delivery catheter.However, attached to the complaint was a photo image of the stretched stent pulled distally from the balloon with the proximal end of the damaged stent positioned over the distal end of the balloon/tip.A microscopic examination identified no kinks or damages.A microscopic examination of the distal extrusion confirmed no evidence of any damages.A microscopic examination of the balloon material identified no tears or holes in the balloon.It was noted that the balloon had been inflated and there was a significant build-up of solidified contrast media inside the balloon.A microscopic examination of the tip identified no damages.Functional testing was performed by inflating the balloon to its rated burst pressure (rbp) and no leaks were noted.A vacuum was pulled and the balloon deflated fully with no resistance.The balloon was inflated to its rbp on three more occasions with no issues noted.No other issues were noted with the device.

• 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: 18907884
• Report Number: 2124215-2024-13703
• Device Sequence Number: 7589146
• Product Code: NIQ
• UDI-Device Identifier: 08714729981053
• UDI-Public: 08714729981053
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 05/14/2024

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: 06/18/2025
• Device Lot Number: 0031931279
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2023
• 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