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

Model Number UNK134

Device Problems Bent (1059); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2014

Event Type  Injury  

Event Description

It was reported that stent damage occurred.The target lesion was located in the right common iliac artery (rcia).In (b)(6) 2014, an express ld iliac/biliary premounted stent system was selected and implanted in the target lesion.Three days post procedure, the patient returned and another intervention was performed.It was noted that a non-bsc guide sheath dilator caught the previously implanted express ld iliac/biliary premounted stent system and squeezed the stent.The dilator was removed.Another stent was then implanted to cover the previously deployed stent and the procedure was completed.No further patient complications were reported and the patient's status was fine.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM
• 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: 4395986
• MDR Text Key: 15122531
• Report Number: 2134265-2014-08164
• 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: 12/10/2014

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 Model Number: UNK134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2014
• Initial Date FDA Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: GUIDE SHEATH DILATOR
• Patient Outcome(s): Required Intervention