MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PHENOM

Model Number UNK-NV-FG

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2022

Event Type  malfunction  

Event Description

Medtronic received a report that the pipeline was delivered to the microcatheter, when the tip of the pipeline came out from the mic rocatheter, the pipeline's delivery wire could be pushed, but when it was pulled, the position of the pipeline did not change.It was possible that the pipeline was disconnected from the proximal bumper part, so the pipeline was removed for each microcatheter.The procedure was completed successfully using the same size of pipeline and a new microcatheter.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the internal carotid-para.It was noted the p atient's vessel tortuosity was moderate.Dapt (dual antiplatelet treatment) was administered.There were no postoperative findings related to blood flow imaging.The pipeline was used for on-label use and it was prepared as indicated in the package insert.Ancillary devices include a phenom27 150cm microcatheter.Additional information received reported that it was confirmed under fluoroscopy that the pipeline was disconnected from the proximal bumper part.

Manufacturer Narrative

Product analysis #705039375:equipment used: video inspection system (m-81850), ruler (m-83360), camera (panasonic lumix dmc-zs5), 0.0265¿ mandrel drawing(s) referenced: dwgsfg15xxx-yyyy-zz rev f as found condition: the pipeline flex w/ shield device and phenom-27 micro catheter were returned for analysis within a shipping box and within two resealable plastic biohazard pouches.The already deployed braid was returned further within a third resealable plastic biohazard pouch.Visual inspection/damage location details: the phenom-27 micro catheter hub was separated from the micro catheter and not returned for analysis.The separated edge was found stretched and jagged and therefore likely due to tensile failure.No damages or irregularities were found with the remaining micro catheter body, distal tip or marker band.The pipeline flex w/ shield pusher was found within the micro catheter with the tip coil and dps sleeves found extending out the catheter tip.Resistance was encountered when attempting to retracting the pusher back within the micro catheter and was advanced out.Dried blood was found throughout the micro catheter and on the pipeline flex w/ shield pusher.The hypotube was intact and unstretched and ptfe shrink tubing was found undamaged.No damages were found with the pad restraint, re-sheathing pad or with the proximal bumper.The distal and proximal dps restraints and dps sleeves were found intact.The tip coil was found undamaged.Both braid ends were found fully opened, damaged, and frayed.The middle braid was found slightly damaged.Testing/analysis: the phenom-027 micro catheter segment was measured to be ~153.0cm.As the hub and strain relief were not returned for analysis, confirmation to length specifications could not be determined.The inner diameter was measured to be 0.0265¿ at both ends which is within specification and compatible for use with the pipeline flex w/ shield.The catheter was then tested by running an in-house 0.0265¿ mandrel through microcatheter.The mandrel was inserted into the catheter hub, through the catheter body and out the distal end with resistance encountered throughout.Dried blood was pushed out with the mandrel.Conclusion: based on the analysis findings, the customer report of ¿delivery system stuck during retraction¿ was confirmed.In-house testing found the pusher had resistance within the micro catheter at the dps sleeves.No damages or irregularities were found with the sleeve or micro catheter tip that would contribute towards the resistance and no nonconformance to specification was found.It is likely the dried blood contributed towards the resistance as resistance was encountered due to the blood during in-house testing.The customer report of ¿device opens prematurely¿ could not be confirmed through device analysis as the device was returned with the braid already deployed.It is likely the premature deployment is caused by the reported resistance.Other possible contributors for premature deployment are, high force delivery, operator did not have the sheath properly seated in hub of micro catheter, over-manipulation, pusher torqued/pulled back during insertion or advancing ped inside micro catheter, or user resheaths more than two times.The braid was found damaged, potentially contributing towards the resistance and premature deployment.It is also possible that the damage occurred due to retracting the device against the reported resistance.As the braid was returned already deployed and unprotected, it is not known how much damage had occurred during the procedure.The micro catheter was found broken near the hub and strain relief, potentially caused by the reported resistance.Ngod10 2022-08-28 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: PHENOM
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15440090
• MDR Text Key: 305885649
• Report Number: 2029214-2022-01573
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-NV-FG
• Device Catalogue Number: UNK-NV-FG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1