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

Model Number M001719010

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2015

Event Type  malfunction  

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).

Event Description

Same case as mdr id: 2134265-2015-06604.It was reported that catheter entrapment occurred.The target lesion was located in the carotid artery.After a 190cm filterwire ez¿ crossed the lesion, an 8x21mm, 5f,135cm carotid wallstent® was advanced to treat the lesion.However, during removal of the filterwire ez¿, the device became stuck in the monorail port of the carotid wallstent®.The filterwire ez¿ was then removed from the stent delivery system (sds) by using an ez bent tip retrieval sheath and the sds was also removed from the patient.The procedure was then completed.The stent was implanted fine with no damage noted.No patient complications were reported and the patient's status was fine.

• Brand Name: CAROTID WALLSTENT®
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5113269
• MDR Text Key: 27105309
• Report Number: 2134265-2015-06479
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2018
• Device Model Number: M001719010
• Device Catalogue Number: 71-901
• Device Lot Number: 17715014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2015
• 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: 3.5-5.5 190CM FILTERWIRE EZ¿