MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number	20226
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a stent dislodgement and removal difficulty occurred.The patient presented with peripheral artery disease.Vascular access was obtained via the left radial artery.The target lesion was located in the mildly tortuous and severely calcified subclavian artery.Following pre-dilation of the left subclavian artery, an 8.0x30x135cm express ld iliac/biliary stent was advanced but encountered difficulties in advancing stent through non-boston scientific sheath.During withdrawal, the stent dislodged from the stent delivery system.The pressure was dropped to 018 system in an attempt to drag the stent out with a small balloon behind the stent.Retrieval attempts of the stent failed as there was too much friction.The physician deployed the stent in radial artery with 2.5 mm sterling balloon catheter at 14 atmospheres for 5 seconds.The subclavian stenosis was treated with 035 charger balloon angioplasty only.No stent was deployed in the subclavian.The physician aborted the procedure after the express was dislodged and deployed in the radial artery.No patient complications were reported.The patient was discharged in good condition.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• 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: 15932050
• Report Number: 2124215-2022-47981
• Device Sequence Number: 12395867
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2022

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: 08/25/2025
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0030029083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Race: White