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

Model Number	H7493941828350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001); Foreign Body In Patient (2687)
Date of Event	08/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event - 18 years or older.
Event or Problem Description
It was reported that a shaft break occurred; the patient experienced vessel rupture with bleeding, resulting in surgery.The target lesion was located in the left anterior descending artery (lad).The patient had angiograms performed, and intervention was attempted on the left anterior descending artery.A 3.50 x 28mm synergy xd drug-eluting stent (des) was advanced for treatment, however, during stent inflation, the left anterior descending artery ruptured with bleeding into the myocardium.Upon removal of the system it was discovered the balloon broke with fragments in the lad.An emergent sternotomy/ligation was performed to repair the lad.Ultimately the patients lad was not able to resolve and rapid, massive blood infusion was needed.No bypass was performed as the patient has large circumflex and right coronary artery.The patient was then transferred to cardiovascular intensive care unit.

• 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: 15429367
• Report Number: 2124215-2022-33483
• Device Sequence Number: 17325842
• Product Code: NIQ
• UDI-Device Identifier: 08714729981077
• UDI-Public: 08714729981077
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/15/2024
• Device Model Number: H7493941828350
• Device Lot Number: 0028931007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male