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

Model Number	20226
Medical Device Problem Codes	Material Rupture (1546); Activation Failure (3270); Migration (4003)
Health Effect - Clinical Codes	Embolism/Embolus (4438); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, insufficient stent appostion and stent migration occurred.The target lesion was located in the left ostial carotid artery.A 7.0x30x135cm express ld stent was advanced for treatment.However, when deploying the stent the balloon ruptured.The stent was insufficiently apposed and shaped like a dog bone.Upon removal of the balloon, the stent slid at about 1 cm into the aorta.The physician used a balloon catheter in an attempt to position the stent deeper inside the carotid and out of the aorta but the stent would not advance.The stent is placed into the ostium and is protruding 1 cm into the aorta.The stent is covering the lesion and successfully restored flow to 100%.The procedure was completed with no complications reported.The patient was fine and was discharged.
Additional Manufacturer Narrative
B5 describe event or problem updated.
Event or Problem Description
It was reported that balloon rupture, insufficient stent a position and stent migration occurred.The target lesion was located in the left ostial carotid artery.A 7.0x30x135cm express ld stent was advanced for treatment.However, when deploying the stent the balloon ruptured.The stent was insufficiently apposed and shaped like a dog bone.Upon removal of the balloon, the stent slid at about 1 cm into the aorta.The physician used a balloon catheter in an attempt to position the stent deeper inside the carotid and out of the aorta but the stent would not advance.The stent is placed into the ostium and is protruding 1 cm into the aorta.The stent is covering the lesion and successfully restored flow to 100%.The procedure was completed with no complications reported.The patient was fine and was discharged.It was further reported that the 60-65% stenosed target lesion was tortuous and calcified.The balloon ruptured during the initial inflation at 2-3 atmospheres.
Event or Problem Description
It was reported that balloon rupture, insufficient stent a position and stent migration occurred.The target lesion was located in the left ostial carotid artery.A 7.0x30x135cm express ld stent was advanced for treatment.However, when deploying the stent, the balloon ruptured.The stent was insufficiently apposed and shaped like a dog bone.Upon removal of the balloon, the stent slid at about 1 cm into the aorta.The physician used a balloon catheter in an attempt to position the stent deeper inside the carotid and out of the aorta but the stent would not advance.The stent is placed into the ostium and is protruding 1 cm into the aorta.The stent is covering the lesion and successfully restored flow to 100%.The procedure was completed with no complications reported.The patient was fine and was discharged.It was further reported that the 60-65% stenosed target lesion was tortuous and calcified.The balloon ruptured during the initial inflation at 2-3 atmospheres.It was further reported that the stent was pulled into the aorta when the balloon was removed and that it was the lesion that held the stent into place preventing it from falling completely out of the ostium of the carotid.
Additional Manufacturer Narrative
Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was present in the balloon which is indicative of a leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole leak approx.1mm proximal from the distal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.The stent was not returned for analysis.No issues were noted with the of the device's tip.No issues were identified with the returned device during analysis.
Additional Manufacturer Narrative
(h6) patient codes: changed from e2403 to e0503.(h6) impact codes: removed f12.(h6) device codes: added a010402.(h6) evaluation conclusion codes: changed from d1001 to d1103.Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was present in the balloon which is indicative of a leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole leak approx.1mm proximal from the distal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.The stent was not returned for analysis.No issues were noted with the of the device tip.No issues were identified with the returned device during analysis.
Event or Problem Description
It was reported that balloon rupture, insufficient stent appostion and stent migration occurred.The target lesion was located in the left ostial carotid artery.A 7.0x30x135cm express ld stent was advanced for treatment.However, when deploying the stent the balloon ruptured.The stent was insufficiently apposed and shaped like a dog bone.Upon removal of the balloon, the stent slid at about 1 cm into the aorta.The physician used a balloon catheter in an attempt to position the stent deeper inside the carotid and out of the aorta but the the stent would not advance.The stent is placed into the ostium and is protruding 1 cm into the aorta.The stent is covering the lesion and successfully restored flow to 100%.The procedure was completed with no complications reported.The patient was fine and was discharged.It was further reported that the 60-65% stenosed target lesion was tortuous and and calcified.The balloon ruptured during the initial inflation at 2-3 atmospheres.It was further reported that the stent was pulled into the aorta when the balloon was removed and that it was the lesion that held the stent into place preventing it from falling completely out of the ostium of the carotid.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11394639
• Report Number: 2134265-2021-02548
• Device Sequence Number: 11588786
• Product Code: NIO
• UDI-Device Identifier: 08714729579694
• UDI-Public: 08714729579694
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/12/2021

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: 11/14/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024774869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 02/24/2021; 03/12/2021; 04/22/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 03/04/2021; 03/26/2021; 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR