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

Model Number PED-350-30

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

Patient Problems Death (1802); Hemorrhage, Subarachnoid (1893); Perforation (2001); No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2018

Event Type  Death  

Manufacturer Narrative

The pipeline was not returned as it was implanted in the patient.The cause of the hemorrhage and death cannot be reliably determined; however, per the reported information and review of ifu, the most likely cause of the event was the procedure, medication and patient condition.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.There is no evidence suggesting that the device was defective, but rather a procedure related event.However, the exact cause of the hemorrhage and death remain unknown.Hemorrhage and death are known inherent risk 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 the patient experienced a serious subarachnoid hemorrhage (sah), suspected m1/2 junction vessel perforation by ped tip coil.Contrast leakage in m1/2 junction, showed vessel bleeding.The tip coil of the ped was suspected to have perforate the vessel during deployment from microcatheter.The aneurysm was in the left internal carotid artery (ica) ophthalmic region.The aneurysm was unruptured, saccular, with a max diameter of 23.6mm and a neck diameter of 10mm.The distal and proximal landing zones were both 10mm.The anatomy was moderate in tortuosity.Patient age was reported to be around (b)(6) and was diagnosed with a left ica, ophthalmic, giant aneurysm (dome size 23.6mm).Bi-axial approach was planned with loose packing of 2 axium complex and pipeline flex across the aneurysm neck.The tip of the microcatheter was positioned at m1/2 region and vessel perforation was suspected during protrusion of ped tip-coil.Contrast leakage was observed under dsa and two more flow diverters (fred jr.Microvention/ competitor devices) were placed within the bleeding location across the m1/2 region.The patient was reported to have expired 3 days post the initial procedure.The death was alleged to have been a result of the sah.

• 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: 7545576
• MDR Text Key: 109293800
• Report Number: 2029214-2018-00456
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2018

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 Model Number: PED-350-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/25/2018
• 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; Required Intervention
• Patient Age: 59 YR