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

Model Number	39201
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent partial deployment occurred.The 90% severe stenosed target lesion was located in a mildly tortuous and moderately calcified left femoral artery.The patient was in a supine position, whose right femoral artery was punctured.After a 7f non-boston scientific puncture sheath was delivered and 0.035 amplatz guide wire crossed the lesion, a 6 x 120 x 120 epic vascular stent was advanced for treatment.The stent reached the lesion, of which the tip was deployed by rolling the shaft.However, after that, angiography showed that the stent could not continue to be deployed even after multiple attempts.Later, the 7f non-bsc sheath was advanced, and the stent was completely recaptured into the sheath.Both devices were removed together from the patient.The procedure was completed with another of same device.No patient complications were reported, and the patient was in good condition.
Additional Manufacturer Narrative
Device evaluated by mfr.: epic vascular 6x120x120 was received for analysis.A visual and tactile examination found the shaft of the device to be kinked at the strain relief of the rack.This type of damage is consistent with excessive force being applied to the delivery system.The device was received with the stent partially deployed on the delivery system.No damage or issues were noted with the stent.A visual examination identified no issues with the handle of the device.The safety lock was also in place on the rack.This concludes the product analysis.
Event or Problem Description
It was reported that stent partial deployment occurred.The 90% severe stenosed target lesion was located in a mildly tortuous and moderately calcified left femoral artery.The patient was in a supine position, whose right femoral artery was punctured.After a 7f non-boston scientific (bsc) puncture sheath was delivered and 0.035 amplatz guide wire crossed the lesion, a 6 x 120 x 120 epic vascular stent was advanced for treatment.The stent reached the lesion, of which the tip was deployed by rolling the shaft.However, after that, angiography showed that the stent could not continue to be deployed even after multiple attempts.Later, the 7f non-bsc sheath was advanced, and the stent was completely recaptured into the sheath.Both devices were removed together from the patient.The procedure was completed with another of same device.No patient complications were reported, and the patient was in good condition.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• 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: 16230378
• Report Number: 2124215-2023-00775
• Device Sequence Number: 20183447
• Product Code: NIO
• UDI-Device Identifier: 08714729805229
• UDI-Public: 08714729805229
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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 Expiration Date: 05/30/2026
• Device Model Number: 39201
• Device Catalogue Number: 39201
• Device Lot Number: 0027407455
• 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: 12/30/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 01/23/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 65 KG