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

Model Number	39202
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that stent fracture occurred.On (b)(6) 2021, the patient presented due to upper gastrointestinal bleeding and tips (trans intrahepatic portal shunt) was performed, and the procedure was successful.On (b)(6) 2022, computed tomography revealed that the stent was fractured.At the time of the report, there were no obvious symptoms.
Event or Problem Description
It was reported that stent fracture occurred.On (b)(6) 2021, the patient presented due to upper gastrointestinal bleeding and tips (intrahepatic portal shunt) was performed, and the procedure was successful.On january 8, 2022, computed tomography revealed that the stent was fractured.At present, there are no obvious symptoms, and the patient hoped to remove the stent.It was further reported that the stent broke into two pieces and interventions were performed in response to retrieved the device fragments.The patient condition was good.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6) hospital).
Event or Problem Description
It was reported that stent fracture and death occurred.On (b)(6) 2021, the patient presented due to upper gastrointestinal bleeding and tips (trans intrahepatic portal shunt) was performed, and the procedure was successful.On (b)(6) 2022, computed tomography revealed that the stent was fractured.At present, there are no obvious symptoms, and the patient hoped to remove the stent.It was further reported that the stent broke into two pieces and interventions were performed in response to retrieve the device fragments.The patient condition was good.It was further reported that in (b)(6) 2021, the shunt channel was set up artificially between the hepatic vein and the main branch of portal vein.The procedure was successful and was the most difficult procedure in the interventional department.The procedure was performed through a special puncture kit (it should be cook's rups100) through the jugular vein, then through the inferior vena cava to the hepatic vein, where the puncture kit was used to penetrate the liver.The device was delivered through the portal vein and into the portal vein to establish an artificial channel from the hepatic vein to the liver parenchyma to the portal vein through a guide wire.The varicose vein was then checked first to see if embolization was needed, and if it was needed to be treated with a coil or liquid embolization agent.The stent was then pre-dilated by 1-2 balloons and was placed.The stent was longer than covered stent, and this procedure used a bsc epic (bare stent) plus a non-bsc stent.In (b)(6) 2022, follow-up ct examination revealed stent fracture and there was no obvious and life threatening symptoms at that time.Since there was no movement noted in the part of the liver, they thought epic fracture was to be a relatively rare case.The patient was the admitted to the cardiothoracic surgery department of the first affiliated hospital of (b)(6) school of medicine for open surgery to remove the fractured stent.However, one day before the procedure, the fractured stent was found to have entered the inferior vena cava through the hepatic vein and an open chest procedure was required.The procedure was not performed because the patient's family did not agree to open the chest.Later in (b)(6) 2022, the patient died.The patient's death occurred outside the hospital and there was no medical identification of the time and cause of death of the patient.
Additional Manufacturer Narrative
B2 date of death: patient died later in (b)(6) 2022.B5 describe event or problem has been updated b6 relevant tests/laboratory data has been updated b7 other relevant history has been updated h6 patient codes updated to foreign body in patient.H6 impact codes updated from serious injury to death.------------------------------------------------------------------------------------- e1 initial reporter facility name: ((b)(6) hospital).

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13446080
• Report Number: 2134265-2022-00638
• Device Sequence Number: 19913714
• Product Code: NIO
• UDI-Device Identifier: 08714729805564
• UDI-Public: 08714729805564
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2025
• Device Model Number: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0026302958
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 03/21/2022; 06/06/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/08/2022; 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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
• Outcome Attributed to Adverse Event: Death; Other
• Patient Age: 64 YR
• Patient Sex: Male