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

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

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

Event Date 09/20/2010

Event Type  Injury  

Manufacturer Narrative

Based on the reported information, there was no reasonably suggestion that a quality deficiency of the ped occurred.Neurological deterioration and stroke are known inherited complications that may have been caused by hemodynamic changes induced by the procedure.Per the reporting author/s: the events may be attributable to the coverage of regional lenticulostriate branches with multiple peds as well as technical complexities encountered during the placement of telescoping peds and an anchoring neuroform stent as well as the subsequent coiling of the giant (25 mm) aneurysm.The exact caused cannot be determined and remains unknown.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure complication and patient condition related event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report through literature review of ¿the pipeline embolization device for the intracranial treatment of aneurysms trial¿ (p.K.Nelson, p.Lylyk, i.Szikora, s.G.Wetzel, i.Wanke, d.Fiorella).31 patients with 31 aneurysms were enrolled between january and may 2007.25 patients were women.Average age was 54.6 years (range, 35¿76 years).In the one unsuccessful ped placement, there was diminished flow in the parent internal carotid artery (ica) following deployment of the ped and coiling of the remnant aneurysm sac.During angioplasty performed to correct the attenuated flow, the ica beyond the implant was ruptured.The indwelling ped and aneurysm coils were removed during an attempted surgical repair of the ruptured artery, and the carotid artery was ultimately ligated.Two patients had major stroke.The patient with iatrogenic rupture of the distal ica had a large left-hemisphere stroke.A second patient experienced a periprocedural stroke manifest as right-sided hemiparesis and motor aphasia following reconstruction of the m1 segment of the left mca with 2 overlapping peds and a neuroform stent followed by coil embolization of a giant m1 aneurysm.Ct imaging 2 days after the procedure showed a left deep gray matter infarction.Speech function improved significantly during the periprocedural hospitalization with marked additional improvement observed at the 30-day postprocedural visit.

• 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: 7459059
• MDR Text Key: 106453899
• Report Number: 2029214-2018-00346
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• 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: 03/30/2018
• 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