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

Model Number PED-500-20

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

Patient Problem Perforation (2001)

Event Date 04/26/2016

Event Type  Death  

Manufacturer Narrative

The pipeline flex was implanted in the patient and will not be returned for evaluation.The reported event could not be confirmed and the cause of the event could not be conclusively determined.Aneurysm rupture is a known inherent risk of flow diversion procedure and is documented in the pipeline flex instruction for use.It should be noted that pipeline flex instructions for use provides the following guidance, "after the entire pipeline flex embolization device is deployed, advance the micro catheter through the device making sure not to dislodge the braid.When the micro catheter tip is distal to the pipeline flex embolization device, retract the delivery wire into the micro catheter tip." all mdrs related to this event: 2029214-2016-00332 ¿ first pipeline flex (ped-450-35) 2029214-2016-00333 ¿ second pipeline flex (ped-475-35) 2029214-2016-00334 ¿ third pipeline flex (ped-500-20).

Event Description

Medtronic received report of aneurysm rupture during a pipeline flex procedure.The patient was undergoing flow diversion treatment of an unruptured, saccular aneurysm in the right paraclinoid internal carotid artery.The vessel was reportedly not tortuous.Max.Diameter was 18mm and neck width was approximately 8mm.Landing zone artery size was 3.8mm distal and 4.8mm proximal.All devices were prepared as indicated in the ifu.It was reported that three pipeline flex devices were placed overlapping one another.The devices were placed in a vessel curve.It was reported that the physician chose to implant three overlapping devices due to the patient's vasculature, but an exact reason was not provided.The first pipeline flex (ped-450-35) was placed most distally, then a pipeline flex (ped-475-35) more proximally, and a third pipeline flex (ped-500-20) was placed most proximally.After placement of the third pipeline flex, the physician advanced the catheter to capture the delivery wire, but the catheter advanced in an unintended direction.In addition, the physician noticed that the first and second pipeline flex devices no longer overlapped.After some difficulty, the physician was able to advance the catheter distally and took a contrast image, which showed the aneurysm was ruptured.The reason for rupture could not be identified.Coils were used to pack the ruptured aneurysm.Peripheral artery occlusion of the ica was also performed.The procedure was converted to an open surgery.Details of the open surgery are not available, but it was likely decompression.The patient passed away five days post-procedure.A cause of death was not identified.

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 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 5672363
• MDR Text Key: 45685704
• Report Number: 2029214-2016-00334
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2018
• Device Model Number: PED-500-20
• Device Lot Number: A156312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Date Device Manufactured: 09/03/2015
• 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: 74 YR