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

Lot Number	0028867402
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: use the first day of the month of the aware date as the event date, as it was not provided.A synergy xd mr us 2.25 x 38mm stent delivery system (sds), catheter was returned for analysis.Visual, tactile, microscopic and functional analysis was performed on the device.No issues were identified with the hypotube shaft.The inner polymer extrusion was stretched, 6.4 cm from tip of the device.There was no sign of damage, stretching or lifting of the stent struts.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.The bumper tip showed no signs of distal tip damage.There was a kink noted in the lasercut section, 2.5 cm from the port exchange.The device was attached to an encore inflation unit and an attempt to inflate the balloon, however, a leak was noted where the kink was in the lasercut section.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that shaft hole occurred.The target lesion was located in the left anterior descending artery.A 2.25 x 38mm synergy xd drug eluting stent was advanced for treatment.During the procedure, the stent balloon would not inflate.It was found that contrast was leaking out of the stent delivery catheter.The device was pulled out and shaft pinhole was noted.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

• 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: 18027079
• Report Number: 2124215-2023-59195
• Device Sequence Number: 7556966
• Product Code: NIQ
• UDI-Device Identifier: 08714729980773
• UDI-Public: 08714729980773
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 10/27/2023

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: 02/09/2024
• Device Lot Number: 0028867402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• 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