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

Model Number PED-475-25

Device Problem Activation Failure (3270)

Patient Problem Fistula (1862)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

The pipeline flex was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.However, the device is pending return.Upon receipt of the device a supplemental report will be filed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during treatment of cerebral aneurysm with a medtronic flow diversion device, it did not open at the proximal end.The physician stated that the internal carotid-cave 15 mm blood vessel distal to the aneurysm was tortuous.Prior to the reported event, the medtronic guide catheter was advanced until it could go no further (distal of the aneurysm), and then they started to deploy the flow diversion device.The medtronic flow diversion device opened up several mm from the tip of the flow diversion device, but it did not open at the proximal end despite several attempts at deploying it.As the physician decided to discontinue the attempts, the patient complained about pain.Also, during the angiography with contrast, a carotid cavernous fistula (ccf) was found, so they stopped using the reported product.The vessel was severely tortuous.The procedure was not completed.After that procedure, coiling therapy was carried out with tve, but the condition did not recover, and an operation was performed the other day.It was reported that the patient¿s condition was stable.

Manufacturer Narrative

Type of report: additional information.Follow-up type: additional information.Device evaluation: device returned.The pipeline flex was returned for evaluation.As received, the device was within the catheter.For further examination, the pipeline flex was pushed out from the catheter with no issue.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 fully opened and severely frayed.No bend was found on the pushwire.No damages were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.No other anomalies were observed.Based the analysis findings, the customer report of ¿failure to open at the proximal end¿ could not be confirmed.The event cause could not be determined as the distal and proximal ends of the returned pipeline flex braid appeared fully opened and severely frayed.The damage on both ends of the pipeline flex braid is likely the result of the customer re-sheathing the device more than recommended two times.It is possible that the "severe vessel tortuosity" and "damaged braid" may have contributed to the reported issue.All products are 100% inspected for damages and irregularities during manufacture.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: 8061873
• MDR Text Key: 126922482
• Report Number: 2029214-2018-00935
• 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: 02/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2021
• Device Model Number: PED-475-25
• Device Lot Number: A628385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 02/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention