MAUDE Adverse Event Report: MEDTRONIC, INC GUARDWIRE TEMPORARY OCCLUSION SYSTEM; CATHETER, EMBOLECTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

Lit ref: https://doi.Org/10.1016/j.Jstrokecerebrovasdis.2017.09.041.If information is provided in the future, a supplemental report will be issued.

Event Description

As part of the study, carotid artery stenting (cas) procedures were performed on patients using non-medtronic stents.Medtronic export aspiration catheters and medtronic guardwire embolic protection devices were amongst the devices used during the procedures.Successful dilatation of the carotid lesion was obtained from all patients.No permanent hemorrhagic or ischemic complications were observed in the series.Transient ischemic attack occurred in 2 cases (6.7%) in group h and in 1 case (1.3%) in group n, respectively.Minor strokes, which were defined as new neurological deficits that were completely resolved within 30 days of follow-up, were observed in only 3 (3.9%) cases in group n.

• Brand Name: GUARDWIRE TEMPORARY OCCLUSION SYSTEM
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8559859
• MDR Text Key: 143390672
• Report Number: 1220452-2019-00051
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 04/29/2019
• 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 Age: 72 YR