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

Model Number PED-475-35

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

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

The device was implanted and will not be returned for evaluation; product analysis will not be performed.Based on the reported information, there did not appear to have been any defect of the device during use.Per the provided information, review of ifu to investigate the complaint, the most likely cause of the event was patient condition and procedure related.Linked mdr's 2029214-2018-00156.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the patient had neurological deterioration 2 days status post placement of pipeline flex embolization devices (ped) for the treatment of carotid cavernous fistula (ccf).It was reported the patient's ped placement procedure was completed and the physician expected the patient's ccf would thrombose and disappear.The patient's condition worsened after 2 days, and needed re-embolization with coils to control bleeding.The bleeding could not be completely controlled.An magnetic resonance angiogram was taken 7 days after the intervention.It could not be confirmed if the ccf still existed.The patient's left eye remained closed.Her condition was being monitored.

• 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 ; 9496801224
• MDR Report Key: 7305704
• MDR Text Key: 101248788
• Report Number: 2029214-2018-00157
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Model Number: PED-475-35
• Device Lot Number: A517472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• Date Device Manufactured: 08/31/2017
• 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): Required Intervention