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

Model Number PED-450-35

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

Patient Problems Edema (1820); Neurological Deficit/Dysfunction (1982)

Event Date 12/22/2015

Event Type  Injury  

Manufacturer Narrative

The device was reported to have performed as intended; as indicated by successful deployment, therefore it was not returned.No treatment was reported to have been required for the vision event or for the mass effect.Neurological deficits are known inherent risk of intracranial procedure and are documented in the devices instruction for use.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure related event.There is no evidence suggesting that the device was defective.The patient's clinical status did improve as evident by mrs of 1 from 2.Per the reported information, and review of ifu, the most likely cause for the worsening of mass effect and vision issue may have been changes in the flow of blood.However, an exact caused cannot be determine.

Event Description

Medtronic received report that post procedure, the patient had eye movement disorder and the mass effect worsen.The aneurysm was in the right ic-cavernous, unruptured, saccular, with size: max diameter 19.0 mm, neck width 16.0 mm.Baseline mrs was 0.On the 4th day post intervention, the patient was reported to have mrs: 2 (mass effect: yes (got worse)).At 6 month follow up the mrs was 1 and the vision issue had resolved but the mass effect remained.

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: 6586629
• MDR Text Key: 75815382
• Report Number: 2029214-2017-00695
• 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: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/20/2018
• Device Model Number: PED-450-35
• Device Lot Number: A150539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Date Device Manufactured: 08/21/2015
• 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
• Patient Age: 71 YR
• Patient Weight: 49