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

Model Number	H7493941832270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 2.75 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during introduction, the proximal shaft broke.The device was pulled by the physician from the patient and the procedure was completed with a 2.75x34mm non-boston scientific stent.No patient complications were reported and the patient was expected to fully recover.
Additional Manufacturer Narrative
Updated: (e4) init rptr also sent rep to fda: changed from no to yes.(g2) report source: added user facility.
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified left anterior descending artery.A 2.75 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during introduction, the proximal shaft broke.The device was pulled by the physician from the patient and the procedure was completed with a 2.75x34mm non-boston scientific stent.No patient complications were reported and the patient was expected to fully recover.It was further reported that this is the same case as user facility maude report #mw5104204.

• Brand Name: SYNERGY XD
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12576786
• Report Number: 2134265-2021-12192
• Device Sequence Number: 14283378
• Product Code: NIQ
• UDI-Device Identifier: 08714729980926
• UDI-Public: 08714729980926
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: 03/16/2023
• Device Model Number: H7493941832270
• Device Lot Number: 0027032214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 81