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

Lot Number	0029948328
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 2.25 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the balloon failed to inflate and was broken.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr us 2.25 x 24mm was returned for analysis.A visual, tactile and microscopic examination identified no kinks or damages along the entire length of the hypotube and the distal extrusion identified no damage.A microscopic examination of the crimped stent identified that the crimped stent was kinked.This kink was located approximately 7mm distal from its proximal end.The stent was securely positioned between the proximal and distal markerbands.A microscopic examination of the balloon material identified no damages.Device analysis confirmed that no issues existed with the inflation of the balloon.Although visually it was noted that the crimped stent was kinked on the balloon, it was possible to inflate the balloon to its rated burst pressure of 18 atmospheres with no resistance or leaks noted.The stent fully deployed from the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.A 2.25 x 24mm synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, the balloon failed to inflate and was broken.The procedure was completed with another of the same device.No patient complications were 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: 19264975
• Report Number: 2124215-2024-27358
• Device Sequence Number: 6981550
• Product Code: NIQ
• UDI-Device Identifier: 08714729980742
• UDI-Public: 08714729980742
• Combination Product (Y/N): Y
• Initial Reporter State: PR
• 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): 06/17/2024

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: 08/07/2024
• Device Lot Number: 0029948328
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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 Age: 71 YR
• Patient Sex: Female