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

Model Number	20226
Medical Device Problem Codes	Material Rupture (1546); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the subclavian artery.A 7.0x30x135cm express ld iliac / biliary was advanced for dilatation.However, during first inflation at 8 atmospheres the balloon ruptured during initial inflation.The device was simply removed from the patient as the stent was not completely deployed and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter phone: (b)(6).Date of event corrected from (b)(6) 2018 to (b)(6) 2018.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the subclavian artery.A 7.0x30x135cm express ld iliac / biliary was advanced for dilatation.However, during first inflation at 8 atmospheres the balloon ruptured during initial inflation.The device was simply removed from the patient as the stent was not completely deployed and the procedure was completed with a different device.No patient complications were reported.It was further reported that a 7x40mm mustang balloon catheter was used for pre-dilation.During stent implant less than 8 atmospheres, the balloon on the delivery system ruptured.The stent was noted to partially deploy and eventually dislodged.Additional wire and balloons were used to expand the dislodged stent.The device was returned for analysis.The delivery system was returned without the stent.A visual and microscopic examination was performed on the returned delivery system.A visual and tactile examination identified no damage or any issues with the shaft that could have contributed to the complaint incident.A visual examination noted that balloon exhibited signs of having been inflated and was not refolded.No tears were visible in the balloon material.The investigator attached the device to an encore inflation unit and positive pressure was applied and liquid was seen escaping from a pinhole leak in the balloon material at the distal edge of the distal markerband.A visual and microscopic examination identified no issues with the balloon material or distal markerband that could have contributed to the damage identified.A visual and microscopic examination identified no damage or any issues with the tip or markerbands of the returned device.No other issues were identified during the product analysis.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter phone: (b)(6).Device evaluated by mfr updated to include review of angiogram images of the procedure.Device evaluated by mfr.: the device was returned for analysis.The delivery system was returned without the stent.A visual and microscopic examination was performed on the returned delivery system.A visual and tactile examination identified no damage or any issues with the shaft that could have contributed to the complaint incident.A visual examination noted that balloon exhibited signs of having been inflated and was not refolded.No tears were visible in the balloon material.The investigator attached the device to an encore inflation unit and positive pressure was applied and liquid was seen escaping from a pinhole leak in the balloon material at the distal edge of the distal markerband.A visual and microscopic examination identified no issues with the balloon material or distal markerband that could have contributed to the damage identified.A visual and microscopic examination identified no damage or any issues with the tip or markerbands of the returned device.No other issues were identified during the product analysis.Received for this complaint was angiogram images of the procedure.A review of the images confirmed a very distinctive lesion was present (image 1) and after a primary post-dilatation (image 2) a contrast shoot was conducted and an improvement in the vessel lumen is observed (image 3).The stent is positioned covering the lesion (image 4) followed by a deployment in the proximal side and a partial deployment in the center of the stent with the distal area constrained (image 5-6).The images recorded the partially deployed stent in different anatomical location corresponding to the description in the event, where subsequent attempts, to achieve the full deployment, are conducted using different balloons.The last image shows a fully deployed stent.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the subclavian artery.A 7.0x30x135cm express ld iliac / biliary was advanced for dilatation.However, during first inflation at 8 atmospheres the balloon ruptured during initial inflation.The device was simply removed from the patient as the stent was not completely deployed and the procedure was completed with a different device.No patient complications were reported.It was further reported that a 7x40mm mustang balloon catheter was used for pre-dilation.During stent implant less than 8 atmospheres, the balloon on the delivery system ruptured.The stent was noted to partially deploy and eventually dislodged.Additional wire and balloons were used to expand the dislodged stent.

• 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: 7974499
• Report Number: 2134265-2018-62030
• Device Sequence Number: 16555363
• Product Code: NIO
• UDI-Device Identifier: 08714729579694
• UDI-Public: 08714729579694
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2019

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: 03/06/2020
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0020370860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 11/01/2018; 08/12/2019
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/26/2018; 08/20/2019
• 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