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

Model Number PED-275-12

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

Patient Problem Paralysis (1997)

Event Date 02/04/2018

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as it remains implanted; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, there is no evidence suggesting that the device was defective.The event happened in the patient post procedure and cause was unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic receive a report that 3 days post the pipeline embolization procedure, the patient developed left hemiplegia.The event has not resolved and is ongoing and required in-patient hospitalization or prolongation of existing hospitalization.The patient was reported to have been discharged 21 days after the procedure.The patient was also reported to have a cranial trauma and a headache 14 day post the pipeline procedure.Both of these events have resolved without sequelae.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toldeo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toldeo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 7659784
• MDR Text Key: 113063957
• Report Number: 2029214-2018-00596
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: PED-275-12
• Device Lot Number: A113424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2015
• 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): Hospitalization