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

Model Number PED-500-25

Device Problem Activation Failure (3270)

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

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the distal tip of the pipeline could not be opened despite several attempts with different methods; therefore, the pipeline was removed from the patient and it was replaced with a new stent to complete the procedure.The pipeline was deployed about 50% when it failed to open distally.More than two attempts were made to open it without success.One of the attempts to open the pipeline was done with a guide catheter.The pipeline was observed to be damaged at the distal tip of it.The tip of the braid was entangled causing it not to open.It was noted that the distal end of the pipeline was positioned on a bend in patient.No patient injury was reported because of the event.Post procedural angiography showed that the flow of blood slowed down.The patient was undergoing embolization treatment of an unruptured amorphous aneurysm measuring 2.3 mm x 1.4 mm located in the cavernous segment of the right internal carotid artery (ica).The distal and proximal landing zone was 4.23 mm x 5.2 mm.The patient¿s vasculature was moderate in tortuosity.The patient was on dual antiplatelet therapy but the pru level was unknown.There are images for review.The devices were prepared as indicated in the instructions for use.

Manufacturer Narrative

The pipeline flex was returned for evaluation within its inner pouch; inside of a sealed bio-hazard bag and a shipping box.When compared to the drawings the tip coil appeared to be stretched.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation.The distal and proximal ends of the pipeline flex braid appeared to be fully opened and moderately frayed.No bends were observed on the pushwire.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.Based on the analysis findings, the customer report of "failure to open at the distal end" could not be confirmed.The event cause could not be determined.The distal and proximal ends of the returned pipeline flex braid found to be fully opened and moderately frayed.The tip coil was stretched.However, the cause for damage could not be determined.Possible contributing factor of "failure to open at the distal end" includes patient tortuous anatomy and deployment of the device on a bend.The damage to the ends of the pipeline flex braid is likely the results of the physician re-sheathing the device more than recommended two times.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8169998
• MDR Text Key: 130634795
• Report Number: 2029214-2018-01076
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2019

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 Model Number: PED-500-25
• Device Catalogue Number: PED-500-25
• Device Lot Number: A584017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 03/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR