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

Model Number	39200
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 8 x 80 x 120 epic vascular stent was selected for use.However, after unpacking, it was noticed that there was a space at the tip of the stent.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that stent damage occurred.A 8 x 80 x 120 epic vascular stent was selected for use.However, after unpacking, it was noticed that there was a space at the tip of the stent.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter phone: (b)(6) epic vascular 8x80x120 was received for analysis.The device was received with the stent partially deployed on the delivery system.No issues were noted with the stent.Blood and possible body matter was identified on the device.A visual examination identified no issues with the tip of the device.A visual and tactile examination found the sheath of the device to be damaged.This type of damage is consistent with excessive force being applied to the device.A visual examination identified no issues or damage to the handle of the device.The safety lock was in place on the rack 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: 17482572
• Report Number: 2124215-2023-39425
• Device Sequence Number: 15239921
• Product Code: NIO
• UDI-Device Identifier: 08714729805724
• UDI-Public: 08714729805724
• 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): 09/11/2023

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: 0030326335
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2022
• 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 Sex: Unknown