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

Model Number PED2-425-16

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Perforation (2001); No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned, as it was implanted in the patient.Follow up attempts have been made to obtain additional information.However, our attempts have been unsuccessful.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the guidewire was used to assist in opening pipeline device.There was also report of a stent being used during procedure, due to right carotid artery dissection.

Manufacturer Narrative

We have subsequently received additional information therefore are providing an updated report.From the new information received there has been no allegation of a device malfunction.All products are 100% inspected for damages and irregularities during manufacture.This event no longer fits the criteria for mdr reporting.Updated device code.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the guidewire was used only to optimize wall apposition of the pipeline device.No patient injury occurred.

• Brand Name: PIPELINE FLEX WITH SHIELD
• 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: 7522705
• MDR Text Key: 108559592
• Report Number: 2029214-2018-00433
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: HU
• 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,Followup
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2020
• Device Model Number: PED2-425-16
• Device Lot Number: A455931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2017
• 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
• Patient Age: 49 YR