MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	H74937912618900
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent fractured, requiring surgery for removal.The target lesion was located in the moderately tortuous and moderately calcified mesenteric artery.A 6.0mmx18mmx90cm express sd renal/biliary stent balloon expandable was advanced for balloon angioplasty and stent procedure.During the procedure, the physician used an 6f x 45cm angled non-boston scientific (bsc) introducer sheath as a protection in the right common femoral artery to expose the stent.Upon doing so, the stent balloon pulled back.When advancing forward, the stent abruptly released from the balloon shaft.The stent remained undeployed over the non-bsc wire distally.The physician deployed a single loop snare to remove the distal end of the wire and stent.Then, attempted to remove the stent through the 6f non-bsc sheath but without success.The physician then inserted an 8f x 45cm non-bsc sheath in the left common femoral artery to approach from the other side and remove it through a larger sheath.A three-loop snare from the left common femoral artery was inserted and then snared the stent, but then again it was unsuccessful.The physician decided to use an 8x39cm non-bsc stent to cover the express sd stent to the left common iliac.A portion of the right-side snare became stuck to express sd stent and wire tacked down by the non-bsc stent.When pulling back to remove the wire and snare from the right, a portion of the express sd stent remained stuck to the snare and wire.The distal end of the wire and express sd stent broke free.The portion that connects the snare was attempted to be removed through the right common femoral artery access site.Then the portion of the stent that broke free after the 8x39cm non-bsc stent deployment were visible under fluoroscopy and stuck on the access site.This case was not flow-limiting, but an open surgery was done to remove the portion of the wire and stent struts.The patient experienced blood loss.The patient is expected full recovery.
Additional Manufacturer Narrative
D2b pro code (product code): fge, nin.G4 premarket / 510(k) #: k152607, k162404, p060006.
Event or Problem Description
It was reported that the stent fractured, requiring surgery for removal.The target lesion was located in the moderately tortuous and moderately calcified mesenteric artery.A 6.0mmx18mmx90cm express sd renal/biliary stent balloon expandable was advanced for balloon angioplasty and stent procedure.During the procedure, the physician used an 6f x 45cm angled non-boston scientific (bsc) introducer sheath as a protection in the right common femoral artery to expose the stent.Upon doing so, the stent balloon pulled back.When advancing forward, the stent abruptly released from the balloon shaft.The stent remained undeployed over the non-bsc wire distally.The physician deployed a single loop snare to remove the distal end of the wire and stent.Then, attempted to remove the stent through the 6f non-bsc sheath but without success.The physician then inserted an 8f x 45cm non-bsc sheath in the left common femoral artery to approach from the other side and remove it through a larger sheath.A three-loop snare from the left common femoral artery was inserted and then snared the stent, but then again it was unsuccessful.The physician decided to use an 8x39cm non-bsc stent to cover the express sd stent to the left common iliac.A portion of the right-side snare became stuck to express sd stent and wire tacked down by the non-bsc stent.When pulling back to remove the wire and snare from the right, a portion of the express sd stent remained stuck to the snare and wire.The distal end of the wire and express sd stent broke free.The portion that connects the snare was attempted to be removed through the right common femoral artery access site.Then the portion of the stent that broke free after the 8x39cm non-bsc stent deployment were visible under fluoroscopy and stuck on the access site.This case was not flow-limiting, but an open surgery was done to remove the portion of the wire and stent struts.The patient experienced blood loss.The patient is expected full recovery.It was further reported that there was no bleeding due to vessel trauma.The bleeding occurred with the surgical procedure to remove the stent fragment.The access site had to be enlarged and surgical cut down to remove stent fragment.
Additional Manufacturer Narrative
D2b pro code (product code): fge, nin.G4 premarket / 510(k) #: k152607, k162404, p060006.H6 patient code and impact code updated.

• Brand Name: EXPRESS SD RENAL/BILIARY
• Common Device Name: STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20729709
• Report Number: 2124215-2024-72229
• Device Sequence Number: 8370933
• Product Code: FGE
• UDI-Device Identifier: 08714729484851
• UDI-Public: 08714729484851
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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: 08/27/2026
• Device Model Number: H74937912618900
• Device Catalogue Number: H74937912618900
• Device Lot Number: 0032304279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 12/30/2024
• Date Device Manufactured: 08/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: 165CM SPARTACORE; GUIDEWIRE: 165CM SPARTACORE; INTRODUCER SHEATH: 6F, 8F TERUMO; INTRODUCER SHEATH: 6F, 8F TERUMO
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown