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

Model Number PED-350-20

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

Patient Problems Neurological Deficit/Dysfunction (1982); Hydrocephalus (3272)

Event Type  Injury  

Manufacturer Narrative

There report was from a retrospective case review.There was no evidence the device was explanted or available for evaluation.The cause of the event could not be conclusively determined from the reported information.Journal: a<(>&<)>a case reports issue: june 1, 2017 ¿ volume 8 ¿ number 11 article: management of a patient requiring intrathecal drain insertion and removal in the setting of concomitant dual antiplatelet therapy with clopidogrel and aspirin:a case report article: authors: christopher w.Connors, md, and janie d.Nguyen, do linked events: 2029214-2017-00966 2029214-2017-00967.

Event Description

Medtronic received information on a literature case report that 2 pipeline devices were placed for emergent treatment of a patient who had subarachnoid hematoma secondary to a blister aneurysm of the right internal carotid artery.The article reported the patient had symptomatic hydrocephalus requiring cerebrospinal fluid diversion on postoperative day 5.A lumbar drain was placed for the patient.She was reported as " alert, interactive, and following commands with moderate (4/5) weakness on the left side.¿ the day after the lumber drain placement.This drain was removed after 14 days.The patient was discharged to rehabilitation.Per correspondence with the author of the article, the hydrocephalus event was not directly related to the medtronic product.

• 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: 6790241
• MDR Text Key: 82558911
• Report Number: 2029214-2017-00966
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: PED-350-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2017
• 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): Required Intervention
• Patient Age: 63 YR