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

Model Number	H7493941812500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 5.00 x 12mm synergy xd drug-eluting stent was opened; however, when removed from the plastic cover, the shaft was fractured.The procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 5.00 x 12mm; stent delivery system (sds) was returned for analysis.A visual examination of the stent found no issues.The stent was securely crimped between the proximal and distal makerbands.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual, microscopic and tactile examination of the hypotube found no kinks or damages.A visual and microscopic examination of the distal extrusion (inner and outer lumen and mid-shaft) found no issues along the shaft polymer extrusion.
Event or Problem Description
It was reported that shaft break occurred.A 5.00 x 12mm synergy xd drug-eluting stent was opened; however, when removed from the plastic cover, the shaft was fractured.The procedure was completed with another of the same device.There were no patient complications reported.

• 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: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16196259
• Report Number: 2124215-2023-01518
• Device Sequence Number: 4337501
• Product Code: NIQ
• UDI-Device Identifier: 08714729981244
• UDI-Public: 08714729981244
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2023

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: 12/08/2023
• Device Model Number: H7493941812500
• Device Lot Number: 0028606070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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