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

Model Number PED-500-12

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 and 2029214-2017-00738.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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 FLEX
• 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: 6615864
• MDR Text Key: 76821019
• Report Number: 2029214-2017-00738
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• 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

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/26/2019
• Device Model Number: PED-500-12
• Device Lot Number: A366047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2016
• 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