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

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

Patient Problems Intracranial Hemorrhage (1891); Paresis (1998)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned as it was implanted.The device performed as intended; as indicated by successful deployment of the device in the intended landing zone of the internal carotid artery (ica).There was no device issue during the delivery of the implanted device.Intracranial hemorrhage is a known inherent risk of endovascular procedure and is documented in the device's instruction for use.In this event, the cause of the intracranial hemorrhage cannot be determined.The cause of the stroke and the hemorrhage cannot be reliably determined; however, per the reported information, review of ifu, and review of literature to investigate the complaint, the most likely cause for the complaint is the patient¿s medical condition.Linked event: 2029214-2017-00735 2029214-2017-00736 2029214-2017-00737 2029214-2017-00738.

Event Description

Medtronic received report that 3 hours post intervention, the patient experiencing left arm weakness / left sided neglect.Mri showed stroke of primary motor cortex, parietal lobe and gradient echo hypointensity suggestive of micro hemorrhage.Patient is recovering and will require rehab.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6615858
• MDR Text Key: 76820763
• Report Number: 2029214-2017-00737
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

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: 05/10/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: 05/10/2017
• Supplement Dates FDA Received: 10/04/2017
• 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): Disability