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

Model Number PED-300-18

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

Cerejo, r., bain, m., masaryk, t.(2017).Balloon sandwich technique for retrieval of fractured delivery wire of pipeline stent.Interventional neuroradiology, 24(1), 40-42.Doi:10.1177/1591019917732287 the pipeline flex has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found a report of pipeline delivery wire fracture during a procedure.The patient presented with bilateral ophthalmic aneurysms -- the left aneurysm measured 7 mm and right aneurysm measured 4 mm.The left aneurysm was successful treated with a pipeline flex; the physicians then proceeded to treat the right aneurysm also with a pipeline flex.During the procedure, the pipeline flex was deployed.Resheathing was attempted by advancing the microcatheter over the delivery wire.The article states that the proximal markers were successfully recaptured, but the "entire length of the core wire under the device" fractured as the microcatheter neared the distal marker.When it was realized that the wire had fractured inside the microcatheter, retrieval was attempted by manipulating the intermediate catheter and microcatheter.These attempts were unsuccessful and the microcatheter was removed.A gooseneck snare device through the intermediate catheter was attempted, but was also unsuccessful.Afterward, a balloon microcatheter was navigated to the distal end of the intermediate catheter.The balloon was inflated sandwiching the fractured wire between the balloon and intermediate catheter.The entire system was pulled out successfully.The pipeline braid was well apposed to the vessel wall, but during manipulation, the braid migrated down and did not adequately cover the aneurysm neck.A second pipeline flex was placed overlapping the first.There was reportedly good stagnation in the aneurysm.The patient had a normal neurological exam post-procedure.Angiographic follow-up at six months demonstrated complete occlusion of the aneurysm.

Manufacturer Narrative

Event information - additional information.Expiration date, lot number - additional information.Date manufacturer received - additional information.Type of report - additional information.Follow-up type - additional information.Device manufacture date - additional information.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient's weight was not provided, but was described to be "normal" for their height.

• 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: 7447323
• MDR Text Key: 106062916
• Report Number: 2029214-2018-00308
• 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
• Report Date: 07/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2018
• Device Model Number: PED-300-18
• Device Lot Number: A094583
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 06/25/2018
• Supplement Dates FDA Received: 07/22/2018
• Date Device Manufactured: 04/22/2015
• 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: 57 YR