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

Model Number PED-450-25

Device Problems Positioning Failure (1158); Unintended Ejection (1234); Physical Resistance/Sticking (4012)

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

Event Date 06/02/2022

Event Type  malfunction  

Event Description

Medtronic received information regarding a pipeline that had difficult positioning and became stuck in the phenom 27 microcatheter after resheathing.That patient was undergoing a procedure for flow diverter treatment of an unruptured saccular right internal carotid artery (ica) posterior communicating segment aneurysm.The aneurysm max diameter was 9.8mm and the neck diameter was 6.9mm.Vessel tortuosity was normal.It was reported that the devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed per ifu.The tip of the pipeline opened about 6-8mm but it was observed that the distal anchoring position was not ideal so the pipeline was recovered into the phenom 27 microcatheter.The pipeline was only resheathed one time.When trying to deploy the pipeline against, it was found the pipeline was stuck in the phenom 27 microcatheter.After various adjustment attempts, the devices still could not be used normally so they were withdrawn together from the patient's body.A new pipeline and phenom microcatheter were then used to complete the surgery successfully without issue.After the surgery was completed, the complaint pipeline and phenom were inspected and the pipeline pushwire was able to be removed from the phenom 27 microcatheter.The pipeline stent remained in the microcatheter and was observed under dsa to be in trapped in the proximal end of the microcatheter.Attempts were made to remove the pipeline stent from the phenom 27 microcatheter but attempts were unsuccessful.There was no harm or injury to the patient.Additional information received reported that the resistance was in the catheter tip.There was no damage to the pipeline pushwire or catheter observed, and the pushwire was not rotated or pulled back at any time.

Manufacturer Narrative

Device evaluated by mfr: product analysis: equipment used: vis (m-85519), 203cm ruler (m-83361) as found condition: the pipeline flex embolization device and phenom 27 catheter were returned for analysis within a shipping box.The pipeline flex embolization device was returned within a plastic bio-pouch, within an opened pipeline flex outer carton (b305150), and within an opened pipeline flex inner pouch (b305150).The phenom 27 catheter was returned within a plastic bio-pouch, within an opened phenom 27 outer carton (se21-047), and within an opened phenom 27 inner pouch (se21-047).Visual inspection/damage location details: no bends or kinks were found with the pipeline flex pusher.The pusher distal hypotube was found stretched with the shrink tubing pulled back from the proximal bumper.The pusher was found detached at the distal hypotube weld (solder joint).The detached distal segment of the pusher was found still within the introducer sheath.The detached pusher was removed from within the introducer sheath.The pusher distal core wire and tip coil were found bent.The phenom 27 catheter was examined.The catheter hub was found in good condition.The catheter body was found kinked at ~60.0cm from the distal tip.The catheter distal tip was found in good condition.The phenom 27 catheter was flushed, water exited from the distal tip.An in-house mandrel was inserted through the phenom 27 catheter and the pipeline flex braid was pushed out from within the hub.The braid proximal and distal ends were open, but damaged (frayed).Testing/analysis: the detached pipeline flex pusher was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental and failure analysis.The elemental analysis of the detached pusher end shows the presence of tin (sn).Conclusion: based on the device analysis and reported information, the customer¿s ¿resistance during re-sheathing/failure to resheath¿, ¿resistance/stuck during delivery¿ and ¿device opens prematurely¿ reports were confirmed.Damage to the pipeline flex delivery system (distal core wire/tip coil/stretching) and braid (fraying) can occur if the device is advanced/retrieved against resistance.Possible causes of resistance during re-sheathing/failure to resheath include patient vessel tortuosity, resistance during delivery/retrieval, catheter damage, user does not maintain continuous flush, or user resheaths more than 2 times.Possible causes of resistance/stuck during delivery include use of an incompatible catheter, catheter damage, patient vessel tortuosity, user does not maintain continuous flush, or users pulls back on/torques wire while advancing pipeline in microcatheter.The phenom 27 catheter is compatible for use with the pipeline flex embolization device, the patient¿s vessel tortuosity was ¿normal¿, there was no reported resistance during the initial delivery, the pipeline was only resheathed one time, and the pushwire was not rotated or pulled back at any time.Information regarding if a continuous flush was maintained was not reported.It is possible the damage (kinking) found with the returned phenom 27 catheter contributed to the events.However, the cause for the catheter damage could not be determined.Regarding the solder joint separation issue, separation can occur due to excessive force or inadequate solder/tinning.The analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.The proof load of 2.5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint).There was no non-conformance to specification that led to the detachment issue.Furthermore, the review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.The event is reported at this time based on analysis results which indicated a reportable event.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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• 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: 15497016
• MDR Text Key: 306419428
• Report Number: 2029214-2022-01635
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-450-25
• Device Catalogue Number: PED-450-25
• Device Lot Number: B305150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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
• Patient Age: 65 YR
• Patient Sex: Female