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

Model Number PED-400-16

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

Patient Problems Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982)

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

The pipeline flow device was not returned as it was implanted in the patient; therefore, product analysis of the flow device was not able to be performed.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.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 or during the second procedure.There is no evidence suggesting that the devices were defective, but rather a patient condition and post procedure related event, as the patient¿s pru level was slight high (reported to be around 180).It is possible that the hemodynamic changes induced by the flow diverter may have contributed to the reported post procedure events of headache and aneurysm rupture.Delayed aneurysm rupture after flow diversion occurs in approximately 1% of patients, and its mechanism may involve sudden hemodynamic changes in intra-aneurysmal flow pattern or aneurysm wall weakening due to inflammation and proteolytic enzymes within the developing red thrombus.However, the exact cause remains unknown.Headaches and aneurysm rupture are known inherent risks of endovascular procedure and are documented in our device¿s instruction for use (ifu).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that seven days post the uneventful pipeline embolization procedure, the aneurysm ruptured.The patient presented to the emergency department with a severe headache and high blood pressure.The patient was initially treated for a unruptured internal carotid artery in paraophthalmic.The max diameter was 20mm.The pru level was around 180 and the p2y12 was 4.The anatomy was minimal in tortuosity.The patient did require additional medical intervention, which consisted of a drain being placed and 2 additional flow divertors, this was performed 12 days after the initial placement.The patient was reported to still be hospitalized.

• 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: 7940667
• MDR Text Key: 123045855
• Report Number: 2029214-2018-00834
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2019
• Device Model Number: PED-400-16
• Device Lot Number: A270150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2016
• 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