MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC VASCULAR; STENT, ILIAC

Model Number	39200
Medical Device Problem Codes	Positioning Failure (1158); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name, phone: (b)(6).
Event or Problem Description
It was reported that stent inadvertent deployment occurred.The target lesion was located in the subclavian artery.A 9x30x120 epic vascular stent was advanced for use.During flushing, it was noticed that the tip of the stent was open.The procedure was completed with a different device.No patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that stent inadvertent deployment occurred.The target lesion was located in the subclavian artery.A 9x30x120 epic vascular stent was advanced for use.During flushing, it was noticed that the tip of the stent was open.The procedure was completed with a different device.No patient complications reported and the patient status was stable.It was further reported that stenosis was 80% with mild tortuosity and severe calcification with a significant bend of less than 45.
Additional Manufacturer Narrative
E1 - initial reporter information: (b)(6).Device evaluated by mfr.: an epic device was received for analysis.The device was received with the stent partially deployed on the delivery system.A visual examination identified no issues with the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device and no issues identified or damage to the handle of the device.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• 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: 17803191
• Report Number: 2124215-2023-49597
• Device Sequence Number: 15240467
• Product Code: NIO
• UDI-Device Identifier: 08714729805762
• UDI-Public: 08714729805762
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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 Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0031284262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 53 KG