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

Model Number PED-500-25

Device Problems Physical Resistance (2578); Activation Failure (3270)

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

Event Date 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

The pipeline flex has not been returned for evaluation; product analysis cannot be performed.This event is still under investigation; a follow-up mdr will be submitted when investigation is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that a pipeline flex did not open on the distal end during a procedure.The patient was undergoing treatment for an aneurysm in the right cavernous internal carotid artery (ica).The aneurysm was unruptured and saccular.Aneurysm max.Diameter was 15mm and neck diameter was 10mm.The landing zone artery size was 4.93mm distal and 5.16mm proximal.The devices were prepared as indicated in the ifu.It was reported that during the procedure, the physician advanced the pipeline flex around the tortuous, proximal ica with difficulty.Despite the resistance, the pipeline flex was able to be advanced to the treatment area.The physician planned to open the pipeline flex in the straight middle cerebral artery (mca), then ¿drop and drag¿ the device in the ica.The physician reported that despite numerous attempts in different vessel segments, the distal segment of the pipeline flex braid was unable to be opened.The pipeline flex and delivery microcatheter were removed from the patient.Outside of the patient, the pipeline flex was deployed and still showed same appearance as inside the patient.The procedure was completed using a device from another manufacturer.There were no reports of patient injury in association with this event.The patient is reportedly making an uneventful recovery without any clinical impact apparent.

Manufacturer Narrative

Additional information the pipeline flex was not returned for evaluation as it was discarded; product analysis could not be performed.The customer provided a photo for review.Based on review of the image, the report of pipeline flex failure to open at the distal end was confirmed.The distal braid of the pipeline flex appeared not to open due to the damaged braid.It is possible that the damaged braid and moderate vessel tortuosity contributed to the failure to open issue.However, the cause for damage could not be determined.All products are 100% inspected for damages and irregularities during manufacture.Per our instructions for use (ifu): ¿do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis." 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: 7033481
• MDR Text Key: 92927168
• Report Number: 2029214-2017-01251
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2018
• Device Model Number: PED-500-25
• Device Lot Number: A095100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• Date Device Manufactured: 04/23/2015
• 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 Age: 70 YR