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

Lot Number	0031008858
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that shaft break occurred.A 3.50 x 32mm synergy xd drug-eluting stent (des), 3.50 x 38mm synergy xd des, and a 3.50 x 48mm synergy xd des were advanced for treatment.However, during the procedure, the shaft of the three devices were broken.The procedure was completed with an alternative device and there were no patient complications reported.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by manufacturer: synergy xd mr us 3.50 x 32mm stent delivery system was returned for analysis.A visual, tactile, microscopic and dimensional analysis were performed on the device.A visual and tactile inspection revealed multiple hypotube kinks and a break at 29cm distal to the distal end of the strain relief were noted.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A visual, tactile, and microscopic analysis revealed stent struts were lifted at the distal section of the stent.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.The undamaged crimped stent outer diameter was measured by snap gauge and the result was within max crimped stent profile measurement.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft break occurred.A 3.50 x 32mm synergy xd drug-eluting stent (des), 3.50 x 38mm synergy xd des, and a 3.50 x 48mm synergy xd des were advanced for treatment.However, during the procedure, the shaft of the three devices were broken.The procedure was completed with an alternative device and 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: 18949287
• Report Number: 2124215-2024-15918
• Device Sequence Number: 20840740
• Product Code: NIQ
• UDI-Device Identifier: 08714729981084
• UDI-Public: 08714729981084
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: 01/23/2025
• Device Lot Number: 0031008858
• 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: 03/04/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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