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

Model Number PED-400-14

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

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 02/22/2016

Event Type  Death  

Manufacturer Narrative

(b)(4). The pipeline flex will not be returned for evaluation as it was implanted in the patient. Based on the reported information, there did not appear to have been any defect of the device during use. The event occurred in the patient post procedure and its cause was unknown. Intracerebral bleeding is a known inherent risk of flow diversion procedure and is documented in the pipeline flex instruction for use. Daou, et al (2015), in their article "p2y12 reaction units: effect on hemorrhagic and thromboembolic complications in patients with cerebral aneurysms treated with the pipeline embolization device" reported that pru level less than 60 carry higher odds of hemorrhagic complications. In this patient, the pru level was reported to be 44 at the time of the intracerebral hemorrhage. The cause of the ich cannot be definitively determined; however, per the reported information, review of ifu, and review of literature to investigate the event, the most likely cause of the ich is clopidogrel hyper-response.

Event Description

Medtronic received report that a patient experienced an intracerebral hemorrhage (ich) after pipeline flex implantation. The patient received the pipeline flex implant to treat an unruptured, saccular aneurysm in the left paraophthalmic internal carotid artery (ica). The aneurysm measured 12x12x3mm. Parent artery was 5mm. The patient's vessel was moderately tortuous. The patient also had a previously coiled aneurysm in the posterior communicating artery. The pipeline flex was implanted and no device issues were reported during the procedure. Post-procedure angiographic result showed semi-sphere of stagnant contrast in aneurysm, which was expected. Four days post-procedure, the patient reportedly experienced an ich in the left parietal/temporal region and left middle cerebral artery (mca). The bleed was reportedly not due to the aneurysm and there was no subarachnoid hemorrhage (sah). The patient had a living will, so no intervention was performed. The patient passed away one day after the ich.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 5521242
• MDR Text Key: 41006494
• Report Number: 2029214-2016-00159
• 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

• Type of Report: Initial,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 02/05/2018
• Device Model Number: PED-400-14
• Device Lot Number: A054201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 02/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/23/2016 Patient Sequence Number: 1