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

Model Number PED2-500-30

Device Problem Activation Failure (3270)

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

Event Date 07/31/2020

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 pipeline failed to open.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm of the left internal carotid artery with a max d iameter of 8.35mm and a 1.08mm neck diameter.It was noted the patient's vessel tortuosity was minimal.It was reported that the devices were prepared per the instructions for use (ifu).The microcatheter was placed in the proximal segment of the middle cerebral artery (mca).The pipeline stent was then delivered through the catheter and the distal end of the stent was pushed out but failed to open.The system was repositioned to a more proximal location in the mca, fully resheathed, and deployed without the distal end opening.Less than 50% of the stent was deployed, and it was not in a bend.The system was repositioned in the ica distal to the landing zone, but the pipeline still failed to open.It seemed the distal end was stuck to the delivery wire.The distal end of the stent opened slightly but was in a funnel shape.Finally, the stent was resheathed and removed from the patient.Another device was then used to successfully complete the procedure, and there was no injury to the patient as a result of the event.Post-procedure angiographic results showed full perfusion and no problems.Ancillary devices include an envoy 7f, navien a+ 058, phenom27, synchro 14.

Manufacturer Narrative

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.No bend was observed on the pushwire.The distal end of the pipeline flex shield braid appeared not opened due to damaged braid.The proximal of the pipeline flex shield braid was found fully opened and moderately frayed.No defects 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 on the customer¿s photo and analysis findings, the pipeline flex shield was confirmed to have failure to open at the distal end as the distal end was not opened due to damaged braid.However, the event cause and the cause for damage could not be determined.Possible causes for failure to open include patient tortuous anatomy and damage to the pipeline flex shield braid.There was no non-conformance to specification identified that led to the failure to open issue.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: LASER THERAPY PRODUCT
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10365845
• MDR Text Key: 202944039
• Report Number: 2029214-2020-00768
• 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: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2021
• Device Model Number: PED2-500-30
• Device Catalogue Number: PED2-500-30
• Device Lot Number: A743622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 56