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

Model Number PED-500-14

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

Patient Problems Hemorrhage, Cerebral (1889); Hemorrhage, Subarachnoid (1893); Therapeutic Response, Decreased (2271)

Event Date 08/25/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline device 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 could not be conclusively determined from the reported information.Mazur, m.D.(2016, august 25).Rerupture of a blister aneurysm after treatment with a single flow-diverting stent.Neurosurgery, 79(5), e634-e638.Doi:10.1227/neu.0000000000001412 mdrs related to this article: 2029214-2016-01072, 2029214-2016-01073, 2029214-2016-01074.

Event Description

Medtronic received information from literature that a patient experienced a decline and required retreatment after pipeline flex implantation.The patient initially presented with a thunderclap headache, confusion, mild left-sided facial weakness, and left pronator drift (hunt and hess grade 3).A computed tomography (ct) showed thick diffuse subarachnoid hemorrhage (sah) (fisher grade 3) and hydrocephalus.Digital subtraction angiography demonstrated a 4.3 x 2.2mm dorsal variant blister aneurysm of the right internal carotid artery (ica).The parent vessel at the aneurysm site measured 5.1mm in diameter; the cavernous ica measured >6mm in diameter.An external ventricular drain was placed to address early hydrocephalus.A pipeline flex was then implanted to treat the ruptured blister aneurysm.The pipeline flex was deployed with the distal end positioned in the right m1 and proximal end positioned distal to the ostium of the ophthalmic artery.The device covered the ostia of the posterior communicating artery and the anterior cerebral artery.Post-deployment angiogram showed appropriate wall apposition.It was noted that the blister aneurysm continued to opacify without significant contrast stasis.There were no reports of device issues during implantation.The patient continued to have a moderate headache after the procedure.The patient¿s mental status remained intact and neurological deficits resolved.On hospital day 9, the patient experienced another thunderclap headache, loss of consciousness, seizure, following by elevation of intracranial pressure to >40 mm hg, ventricular arrhythmia, and respiratory insufficiency.The patient was intubated and stabilized.Ct scan demonstrated increasing sah and intraparenchymal hemorrhage adjacent to the aneurysm site.An emergent angiogram, however, demonstrated acute thrombosis of the blister aneurysm with severe luminal narrowing of the right m1.Because of concerns of re-rupture of the dorsal variant aneurysm, a second pipeline flex was deployed overlapping the first.

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.

Manufacturer Narrative

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 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6130991
• MDR Text Key: 60989499
• Report Number: 2029214-2016-01072
• 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,Followup,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2018
• Device Model Number: PED-500-14
• Device Lot Number: A080838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Date Device Manufactured: 03/28/2015
• 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): Required Intervention
• Patient Age: 29 YR