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

Model Number 20226

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

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

Event Date 11/11/2022

Event Type  Injury  

Event 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
• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15932050
• MDR Text Key: 304974687
• Report Number: 2124215-2022-47981
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 11/11/2022
• Initial Date FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Race: White