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

Model Number	H7493941820300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in right coronary artery.A 3.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the balloon failed to inflate, and blood was noted in the inflation device.It was noted that the balloon was burst.The device was removed, and 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 3.00 x 20mm stent delivery system (sds), catheter was returned to the complaint investigation site (cis).No issues identified with the hypotube shaft and no issues identified with the outer / mid-shaft sections or the inner lumen of the device.Stent damage was noted where the stent struts were lifted at proximal section.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.No signs of movement, stent was set between the proximal and distal markerbands.Bumper tip showed no signs of distal tip damage.The undamaged crimped stent outer diameter was measured and the result was within max crimped stent profile measurement.The device was soaked in a water bath at 37 degrees celsius and was attached to an encore inflation device.An attempt was then made to inflate the balloon to 16atm as per, synergy xd, using an inflation aid attached however, pressure was unable to maintained as inflation pinhole leak was noted on the polymer extrusion 1cm distal to the port exchange.The encore inflation device was verified before and after the procedure using a druck gauge.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in right coronary artery.A 3.00 x 20mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the balloon failed to inflate, and blood was noted in the inflation device.It was noted that the balloon was burst.The device was removed, and 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; 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: 17057183
• Report Number: 2124215-2023-26407
• Device Sequence Number: 12425823
• Product Code: NIQ
• UDI-Device Identifier: 08714729980971
• UDI-Public: 08714729980971
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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,Followup
• Report Date (Section B): 07/18/2023

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: 06/19/2024
• Device Model Number: H7493941820300
• Device Lot Number: 0029658590
• 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: 05/17/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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: Male
• Patient Race: White