MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

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

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 03/02/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned as it was implanted in the patient.Neurological deterioration is a know inherent risk of endovascular p rocedure and are documented in our device¿s instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that post pipeline implantation, the patient experienced symptoms of a stroke.During the treatment of recurrent wide necked aneurysm.The procedure was completed with 80cm shuttle, phenom plus and phenom microcatheter.Vessel tortuosity was minimal (access was not complicated).Procedure went well - pipeline was placed in m1 and deployed through bifurcation into internal carotid artery (ica) and over the neck of aneurysm.Everything looked fine, but after procedure patient seemed to have symptoms of a stroke.Physician re-visit the images of the procedure and noted a haze (entangled lucency) around phenom plus catheter.Patient was taken for a thrombectomy, but there was no definite clot and she seemed to improve slightly.Definite hits on ct (distal brain), but symptoms improved.Still mild speech issue.The catheters were flushed and used as indicated in the ifu.The access vessel diameter was 4.5 mm.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7375799
• MDR Text Key: 103648501
• Report Number: 2029214-2018-00233
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/27/2018

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: 03/03/2018
• Initial Date FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Other