MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT?; STENT, CAROTID

Model Number H965SCH647080

Device Problems Bent (1059); Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 01/20/2014

Event Type  Injury  

Event Description

Same case as mdr id 2134265-2014-01108.It was reported that in-stent restenosis and stent damage occurred.In (b)(6) 2013, two 8.0x29 carotid wallstents were implanted to treat stenosis in the carotid artery.In (b)(6) 2014, the patient returned with restenosis in the same area.During the procedure, the physician saw a "hole" in one of the wallstents and suspected a "corrosion or rupture of a strut." the physician treated the restenosis with another wallstent.It was found out that the patient flexed his head two times, the last time being a couple of days before the event.It was noted that the patient "overflexed" his head two times, with the last time being a couple of days before the event.No further patient complications were reported and the patient's status was stable.

Manufacturer Narrative

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: CAROTID WALLSTENT?
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3635719
• MDR Text Key: 3990735
• Report Number: 2134265-2014-00476
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2017
• Device Model Number: H965SCH647080
• Device Catalogue Number: SCH-64708
• Device Lot Number: 0016359426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2013
• 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
• Patient Outcome(s): Required Intervention