MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; LASER THERAPY PRODUCT

Model Number	PED-500-12
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the middle segment of the pipeline failed to open.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right internal carotid artery with a max diameter of 30mm and a 10mm neck diameter.It was noted the patient's vessel tortuosity was moderate.It was reported that during deployment, the middle portion of the pipeline would not open despite the physician trying to wag the system and coax the device open.The middle segment of the pipeline was positioned in a bend, more than 50% had been deployed, resheathing was done less than three times, and no additional steps were done to open the device.The pipeline was removed from the patient, and notable trumpeting of the device was observed.The microcatheter was left in place, and a replacement device was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results showed normal slowing of the flow into the aneurysm.
Additional Manufacturer Narrative
Pthe ptfe shrink tubing was found accordioned for the proximal ~5.0cm and retracted for the distal ~2.0cm.The distal hypotube was found stretched.Dried blood was found on the hypotube.When compared to the drawing the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.No damages were found with the distal marker, re-sheathing marker or with the proximal bumper.The braid was returned with the center not fully opened.The braid fully opened during decontamination.Both ends of the braid were found frayed and damaged.Dried blood was found on the braid.No other anomalies were observed.Based on the analysis findings, the customer report of ¿failure/incomplete to open at middle section (hourglass shape)¿ was confirmed as the braid was returned with an incomplete open at the middle section.Possible causes for failure are patient vessel tortuosity, damaged braid, braid improperly sized to anatomy, braid overstretched during deliver, user deploys braid in vessel bend, presence of other indwelling endovascular stent and inappropriate anatomy.The dried blood found on the braid and on the pusher could possibly contributed towards the incomplete open.The customer reported that the braid was implanted within a vessel bend and vessel tortuosity as moderate.The pipeline flex was found damaged.From the damages seen on the ptfe shrink tubing (accordion), hypotube (st retched) and braid (frayed/damaged); it appears there was high force used.It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex shield through the phenom catheter against resistance.Possible contributors towards the failure are patient vessel tortuosity or lack of continuous flush.There was no non-conformance to specifications identified that led to the reported issues.As the micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the failure could not be determined.As the model and lot number was not identified, any compatibility could not be assessed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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
• Common Device Name: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10281142
• Report Number: 2029214-2020-00696
• Device Sequence Number: 596937
• Product Code: OUT
• UDI-Device Identifier: 00847536016897
• UDI-Public: 00847536016897
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2023
• Device Model Number: PED-500-12
• Device Catalogue Number: PED-500-12
• Device Lot Number: B033630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/26/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 64