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

Model Number PED-425-16

Device Problems Break (1069); Retraction Problem (1536); Activation Failure (3270)

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

Event Date 01/25/2018

Event Type  Injury  

Manufacturer Narrative

The pipeline flex braid will not be returned for evaluation as it was implanted in the patient.The pipeline flex delivery system has not been returned for evaluation.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report of pipeline flex pushwire break during a procedure.The patient was undergoing flow diversion treatment for an unruptured, saccular aneurysm in the left internal carotid artery (ica).Vessel tortuosity was described as normal.The aneurysm had a max.Diameter of 3.29mm and neck diameter of 3mm.The landing zone artery size was 3.4mm distal and 4.5mm proximal.The devices were prepared as indicated in the ifu.During the procedure, the pipeline flex was reportedly deployed without difficulty.The physician reportedly saw sub-optimal wall apposition in the proximal section of the pipeline flex, but went ahead with deployment.At recapture of the pipeline flex delivery system, the physician attempted to advance the catheter over the pushwire, but was not able to.Instead, the catheter and pipeline flex pushwire were withdrawn from the patient together.After removal, it was observed that the distal section of the pushwire remained in the artery.Another physician arrived who used a balloon to angioplasty the proximal section of the pipeline flex open.Afterward, the physician used a gooseneck snare to capture the pushwire piece that had detached.The angiographic result post-procedure was good.The patient is reportedly fine.

• 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: 7281373
• MDR Text Key: 100401883
• Report Number: 2029214-2018-00119
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2018
• Device Model Number: PED-425-16
• Device Lot Number: A133593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2018
• Date Device Manufactured: 07/15/2015
• 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: 35 YR