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

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

Patient Problems Ischemia (1942); Thrombosis (2100)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

The devices were implanted and were not returned for analysis.Ischemic events and thrombosis are known inherent risks of the endovascular procedure and are documented in our device¿s instructions for use (ifu).There was no allegation that the devices did not function as desired or that a malfunction occurred during the first procedure or the second.Based on the reported information, there was no reasonably suggestion that a malfunction or quality deficiency of the pipeline device occurred during the treatment procedure.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a patient condition and procedure related event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received the following report through literature review of ¿447 consecutive cases of pipeline flex flow diversion utilizing a novel large-bore intracranial intermediate catheter: nuances and institutional experience with the syphontrak¿.The patients¿ age ranged from 25 to 80 years (mean 57.3 ± 11.6) and 85% were women.The average aneurysm size was 4.8 ± 2.7 mm (range 2¿14).1 patient had a minor ischemic event (nihss score <(><<)> 4) in the periprocedural period.Intra-arterial abciximab was administered in 3 cases of in situ thrombosis due to platelet aggregation immediately after ped flex deployment.These events were reported to have been transient with minor neurological morbidity.

• Brand Name: PIPELINE
• 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: 7448142
• MDR Text Key: 106134664
• Report Number: 2029214-2018-00310
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• 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