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

Model Number 20300

Device Problems Material Deformation (2976); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2022

Event Type  Injury  

Event Description

It was reported that stent damage and stent migration occurred.The 70% target lesion was located in non-tortuous and non-calcified superficial femoral artery (sfa).A 5x100x120 epic stent was deployed to treat the lesion.However, during post-dilatation, the device migrated distally and it was noted that the stent strut was compressed and misaligned in the middle portion of the stent.The lesion was missed due to migration.Furthermore, the physician decided not to removed the device in the distal sfa.Another stent was used to treat and completed the procedure.There were no patient complications nor injuries reported and the patient status was stable.

• Brand Name: EPIC
• Type of Device: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14016533
• MDR Text Key: 288632111
• Report Number: 2134265-2022-03186
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2022
• Device Model Number: 20300
• Device Catalogue Number: 20300
• Device Lot Number: 0024032883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention