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

Lot Number	0030886349
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 24mm synergy xd drug eluting stent was selected for use.However, during unpacking, the part of shaft that has the stent was not attached to the rest of the device.The procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.A 3.00 x 24mm synergy xd drug eluting stent was selected for use.However, during unpacking, the part of shaft that has the stent was not attached to the rest of the device.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 3.00 x 24mm stent delivery system (sds), was returned for analysis.No issues identified with the hypotube shaft.A visual and tactile examination found polymer extrusion break at the site of the wire exchange port (120cm from strain relief).Examination of the crimped stent via scope found no evidence of stent damage.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 damage.No other issues with the device were identified.

• 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: 18149924
• Report Number: 2124215-2023-64381
• Device Sequence Number: 6613058
• Product Code: NIQ
• UDI-Device Identifier: 08714729980988
• UDI-Public: 08714729980988
• Combination Product (Y/N): Y
• 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): 12/15/2023

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: 01/10/2025
• Device Lot Number: 0030886349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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