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

Model Number PED2-500-20

Device Problem Activation Failure (3270)

Patient Problem Vasoconstriction (2126)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the distal segment of the pipeline failed to open.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm of the right internal carotid artery cavernous s egment with a max diameter of 12.6mm and a 6.4mm neck diameter.It was noted the patient's vessel tortuosity was moderate.It was reported that there was easy access and placement of the microcatheter at the target location.Delivery of the pipeline in the microcatheter and to the landing zone was easy.The distal part of the pipeline opened very slowly, and a lazy opening happened until 1/3 of the device was unsheathed.The pipeline was resheathed in the microcatheter by pushing the catheter distal over the sleeves.The sofia was brought over the pipeline while it was unsheathed.The physician then started to deploy the pipeline further, and this was done easily and opened good.The proximal segment also opened very easily.The physician thought they could fix the distal segment of the pipeline by giving it a massage with a j-shaped microwire or a balloon dilation, but this was not possible.It was noted the device was not positioned in a bend, resheathing was performed more than twice, and more than 50% of the device had been deployed when it failed to open.The balloon angioplasty failed, and wall apposition was not attained.However, the pipeline was implanted at the intended location with at least 3mm past the neck on each side of the aneurysm.It was also stated the pipeline missed the landing zone, and the catheter tip moved during deployment.There would be 24 hour follow-up performed, and control with a new angiography.Dual antiplatelet therapy (dapt) was still on the protocol.The pipeline was not prepared per the instructions for use (ifu): the backflush on the pipeline protector hub was not done.It was unknown if there was any patient symptoms or complications associated with the event, but post-procedure angiographic results showed no stasis, occlusion, or thrombosis in the artery.There was very limited spasm proximal in the internal carotid artery.Ancillary devices include a sofia plus 115cm, headyway27, traxcess 14, hyperform.

Manufacturer Narrative

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.

Event Description

Additional information received reported that the patient was asymptomatic, and there was no need for surgical intervention.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10520832
• MDR Text Key: 207054323
• Report Number: 2029214-2020-00915
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2022
• Device Model Number: PED2-500-20
• Device Catalogue Number: PED2-500-20
• Device Lot Number: A911795
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1