MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC

Model Number H74938046830750

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Blood Loss (2597)

Event Date 09/24/2014

Event Type  Injury  

Event Description

Same case as mdr id 2134265-2014-06888.It was reported that vessel perforation, internal bleeding, hypotension, stent explantation and migration occurred.The target lesion was located in the 9mm in diameter left common iliac.A 8.0x30x75cm express® ld iliac / biliary stent was implanted in the proximal left common iliac to the aortic iliac bifurcation.The stent was considered to be well implanted.The physician wanted to expand the stent to a 9mm diameter and advanced a mustang 9x40 balloon and postdilated the stent.The balloon catheter was removed.A soft tipped guide catheter was advanced over a wire; however, the wire was not all the way through the catheter.The catheter had tilt in the tip.When the physician advanced the catheter, the previously implanted stent was snagged.The stent dislodged and floated to the aorta.A vessel perforation and internal bleeding had been discovered in the distal left external iliac.It is unclear when the perforation occurred.The patient¿s blood pressure had lowered really quickly, which enabled the stent to float up to the aorta.The stent was snared and brought to the distal end of the abdominal aorta that the bifurcation of the right iliac.The vessel perforation was treated with the implant of a non-bsc covered stent.The patient was also given medication and a blood transfusion.No additional patient complications were reported and the patient¿s current status is doing well.

Manufacturer Narrative

Age at time of event: over 55 years.(b)(4).Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4197344
• MDR Text Key: 4982017
• Report Number: 2134265-2014-06309
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P090003
• 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: 09/24/2014

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 Expiration Date: 09/08/2016
• Device Model Number: H74938046830750
• Device Catalogue Number: 38046-83075
• Device Lot Number: 16366197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention