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

Model Number	H7493941832300
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.The synergy xd mr us 3.00 x 32mm stent delivery system was returned for analysis.The stent profile and tip profile section of the delivery system were not returned.A visual and tactile examination of the hypotube shaft found multiple kinks along several locations of the hypotube shaft.A shaft break was also noted at 120 cm distal to the distal end of the strain relief.A visual and tactile examination of the shaft polymer extrusion profile could not be performed as this section was not returned.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that stent unable to load the guidewire.A 3.00 x 32mm synergy xd stent was selected for use.However, during insertion the device failed to load the 0.014 guidewire.The device was removed and the procedure was completed successfully with a new 3.0x32 synergy xd stent.There were no patient complications nor injuries reported.However, returned device analysis revealed a hypotube detachment and stent was not returned.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16714658
• Report Number: 2124215-2023-16338
• Device Sequence Number: 17951253
• Product Code: NIQ
• UDI-Device Identifier: 08714729981008
• UDI-Public: 08714729981008
• 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
• Report Date (Section B): 04/11/2023

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: 11/29/2023
• Device Model Number: H7493941832300
• Device Lot Number: 0028510716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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