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

Model Number PED-425-16

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

Patient Problems Nausea (1970); Neurological Deficit/Dysfunction (1982); Paralysis (1997)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

The pipeline was not returned for analysis as it was implanted in the patient.Based on the reported information, there was no allegation that a malfunction or deficiency of the implanted device occurred during the embolization procedure.The exact cause of the reported events is unknown.Neurological deterioration is a known inherited risk of endovascular embolization procedures and is documented in the instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the pipeline was defective, but rather a post procedure and patient condition related event.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 post the procedure, the patient developed word finding difficulty, paresthesia, and dizziness.The cause was reported to have been unknown and continuing.The patient received the pipeline flex to treat a saccular aneurysm in the left, c6 internal carotid artery (ica).The aneurysm dome was 2.8mm and neck diameter was 3.0mm.There was no report of any device issue during the procedure.Full wall apposition was achieved.The patient¿s mrs was 1 at screening and discharge;mrs was 0 at 30-day and 180-day follow ups.The patient¿s nihss was 1 at procedure, discharge, and follow ups.

• 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: 7632775
• MDR Text Key: 112137736
• Report Number: 2029214-2018-00578
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2017
• Device Model Number: PED-425-16
• Device Lot Number: A052266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2014
• 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: 47 YR