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

Model Number PED-500-14

Device Problems Positioning Failure (1158); Material Frayed (1262)

Patient Problems Death (1802); Hemorrhage, Cerebral (1889)

Event Date 10/06/2015

Event Type  Death  

Manufacturer Narrative

The pipeline flex reported in this mdr will not be returned for evaluation as it was implanted in the patient.The reported event could not be confirmed and the event cause could not be determined from the reported information.(b)(4).Reference mdr# 2029214-2015-05102 reference pe# (b)(4).

Event Description

Medtronic received report that a pipeline flex did not open distally.A different pipeline flex was implanted; post-procedure, the patient experienced a hemorrhage and died.The patient was undergoing treatment of an unruptured, saccular aneurysm in the right, supraclinoid internal carotid artery (ica).The aneurysm measured 3.7x3.8mm.The patient's intracranial vascular anatomy was tortuous.The distal and proximal landing zone artery size was 4.4mm and 4.8mm.A heparinized saline flush and a triaxial system were used during the procedure.A microcatheter was navigated distal to the aneurysm and a pipeline flex (ped-500-16, pe 701125350) was advanced to the microcatheter tip.The pipeline flex was partially unsheathed and the delivery system rotated to facilitate stent expansion.The pipeline flex and microcatheter were pulled back to the landing zone distal to the aneurysm.Through a combination of unsheathing, resheathing and wire advancement, the pipeline flex was attempted to be deployed.However, the distal end of the pipeline flex could not be detached from the delivery system and could not be opened.The microcatheter and pipeline flex were removed from the patient.After removal, the pipeline flex was inspected and the distal end appeared to be frayed.Next, a microcatheter was navigated distal to the aneurysm into the right middle cerebral artery (mca).A new pipeline flex (ped-500-14, pe 0701111486) was advanced to the tip of the microcatheter.The pipeline flex was partially unsheathed and the delivery system rotated to facilitate stent expansion.The pipeline flex and microcatheter were pulled back to the appropriate landing zone distal to the aneurysm.Through a combination of unsheathing and wire advancement, the pipeline flex was fully deployed.The procedure was ended without issue.There were no complications during or immediately after the procedure.The patient was transferred to the icu in stable condition.The patient was neurologically at baseline at the end of the procedure and there were no complications during this procedure.Post-intervention findings showed that there was occlusion of the neck of the aneurysm.The pipeline flex was in place without kinking, endoleak, or parent vessel flow restriction.No intracranial branch occlusions are seen.The physician considered the case successful.Seven hours post-procedure, the patient had an acute neurological deterioration.Ct scan identified a metal fragment in the right frontal lobe and showed a large, right fronto-parietal intracranial hemorrhage with midline shift.It was reported that the patient experienced a right-sided intraparenchymal hemorrhage with malignant intracranial hypertension.The patient underwent a decompression craniotomy.The patient died approximately one day post procedure.

• 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: 5199939
• MDR Text Key: 30331373
• Report Number: 2029214-2015-05101
• 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: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2018
• Device Model Number: PED-500-14
• Device Lot Number: A064185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2015
• Date Device Manufactured: 02/25/2015
• 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): Death
• Patient Age: 00045 YR