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

Lot Number	0031650976
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The patient underwent a chronic total occlusion (cto) procedure.A 5.00 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, during post-dilation, the balloon maintained a pocket of fluid at the distal end of the stent balloon, and it was also noted that the shaft sheared and broke into two pieces.The patient condition was stable post-procedure.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr.: synergy xd mr us 5.00 x 28mm stent delivery system (sds), was returned to the complaint investigation site (cis).A visual and tactile examination identified multiple kinks along the length of the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion identified a break in the midshaft 124.5cm distal to the distal end of the strain relief, the inner lumen stretched 8.5cm from the tip and the distal shaft stretched 25cm from the distal tip.No stent was attached to the balloon or returned with the device.The balloon had been subjected to positive pressure and crimp marks visible however there were no tears or pinholes observed.Bumper tip showed no signs of distal tip damage.Inflation attempt could not be performed due to the damage present in the distal shaft.Dimensional analysis included measurement of the undamaged crimped stent outer diameter and the result was within max crimped stent profile measurement.No other issues were identified during analysis.
Event or Problem Description
It was reported that balloon rupture and shaft break occurred.The patient underwent a chronic total occlusion (cto) procedure.A 5.00 x 28mm synergy xd drug-eluting stent was advanced for treatment.However, during post-dilation, the balloon maintained a pocket of fluid at the distal end of the stent balloon, and it was also noted that the shaft sheared and broke into two pieces.The patient condition was stable post-procedure.

• 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: 19978283
• Report Number: 2124215-2024-50370
• Device Sequence Number: 18163520
• Product Code: NIQ
• UDI-Device Identifier: 08714729981282
• UDI-Public: 08714729981282
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 10/21/2024

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: 05/09/2025
• Device Lot Number: 0031650976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2023
• 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