MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED2-425-18

Device Problems Positioning Failure (1158); Positioning Problem (3009)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received a report that the pipeline was placed perfectly during the first pass, but it was a bit distal and the stenosis couldn't be covered with it.During resheathing of the pipeline due to this issue, the microcatheter and pipeline pushed a bit hard into the artery wall.Then, during second deployment of the pipeline the physician noted that the device twisted, so they took the whole system out of the patient.Contrast injection performed showed a perforated ica, so they coiled the ica with coils 1 plug, and glue.The patient was undergoing surgery for treatment of an unruptured, saccular cavernous segment of the left ica with a max diameter of 4.3mm.Dual antiplatelet treatment was administered which showed a pru level of 98%.Post procedure angiographic results showed an open acom, left ica closed with plug, coils, and glue.Distally of the left media was the small ischemic stroke, delay of 1.6s regarding right media.Ancillary devices include a 6fr destination long sheath 90cm sheath, 6f benchmark 071mp, lot f89067 guide catheter, synhcro 0.014" guidewire.

Manufacturer Narrative

H3: the pipeline flex shield returned within of the phenom 027 catheter; within the outer carton; inside of a biohazard bag and a shipping box.For further examination, the pipeline flex with shield was then pushed out from the catheter lumen with no issues.When compared to the drawings 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 outer diameter (o.D) of the re-sheathing pad was measured within specifications (~0.5857mm).No bends found on the pusher.No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip, marker band and body were examined; and no damages were found.No flash or voids molded were observed in the hub.The catheter was flushed with water and water exited out from the catheter tip.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter hub.The mandrel successfully passed through the catheter hub, lumen and tip with no issues.No other anomalies were observed.Based on the analysis findings, the customer reports of "movement during deployment" and " and "difficult placement/positioning" could not be confirmed and the root cause could not be determined.No damages were found with the pipeline flex with shield and the phenom catheter.Based on the review of the imaging confirm presence of large/giant aneurysm of the left internal carotid artery at the cavernous segment.Further review showed some dye extravasation suggesting a perforation at that level at the parent of the aneurysm/parent artery interface.Parent artery occlusion sacrifice was successfully achieved with mvp, coils and glue with visualization on the anterior communicating artery maintained.There was no non-conformance to specifications identified that led to the reported issues.The customer reported that the patient vessel tortuosity was normal and the devices were prepared per the ifu.In addition, the continuous flush was maintained during delivery.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 W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8765027
• MDR Text Key: 150280925
• Report Number: 2029214-2019-00683
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-425-18
• Device Catalogue Number: PED2-425-18
• Device Lot Number: A778693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR