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

Model Number PED2-400-25

Device Problems Material Deformation (2976); Activation Failure (3270); Physical Resistance/Sticking (4012)

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

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received report that during the procedure the pipeline flex with shield encountered resistance when advanced through the phenom catheter.The pipeline flex with shield braid was alleged to have failed to open at the distal end.The pipeline flex with shield was also reported to have been cut, leaving the braid uncontrollable and unable to be advanced.Upon attempts to retrieve the braid, it locked up halfway inside and outside.The whole system had to be removed.The devices were replaced and a new ped2 (b011771) was used to treat the patient.The customer was notified to return the device for analysis.Ancillary devices: phenom 27, avigo 0.014.The devices were all prepared and used per the instructions for use (ifu).The device was not placed on a bend.Less than 50% of the braid had been deployed when the device failed to open.The device was resheathed less than or equal to 2 times.The device was resheathed and removed with the catheter.No patient injury occurred.The patient was on aspirin and clopidogrel.The post procedure angiography results were okay.The patient was being treated for a right intra-cavernous, right, unruptured, saccular aneurysm.The max diameter was 30 mm and the neck was 10 mm.The distal landing zone was 4 mm and the proximal was 3 mm.The vessel anatomy was severe in tortuosity.Additional information: the pipeline pushwire break was not separate into 2 difference pieces.The center-wire was only cut.It is unknown how the pipeline braid was ¿cut¿.No force was used when handling the device.The provided information has been confirmed with the physician.The device will be returned for analysis.There was no resistance when the pipeline was advanced through the phenom catheter.The pipeline device and the phenom will be returned for analysis.Images have been attached.

Manufacturer Narrative

For further examination, the phenom 27 catheter was cut to remove the pipeline flex shield.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 appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the pipeline flex shield braid were found fully opened and frayed.Bends were found at 11.0cm to 25.5cm from the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the phenom 27 catheter were measured to be within specifications.The catheter tip and marker were examined; no damages were found.The catheter body appeared to be accordioned at 1.5cm to 12.5cm from the distal tip.No flash or voids molded were observed in the hub.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip; however, resistance was observed at the damaged locations.No other anomalies were observed.Based on the returned devices, the pipeline fl ex shield and phenom 27 catheter were confirmed to have ¿resistance during delivery¿ and ¿catheter resistance¿ issues as the returned pipeline flex shield was found stuck inside the phenom catheter.However, the pipeline flex shield was not confirmed to have "failure to open at the distal end" issue as the distal end of the pipeline flex shield braid was found opened and frayed.From the dama ges seen on the catheter (accordioning ), pusher (bending), pipeline flex shield braid (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance the pipeline flex shield through the phenom catheter against the resistance.It is likely that the severe vessel tortuosity may have contributed to the reported issues.There was no non-conformance to specifications identified that led to the reported issues.Per our instructions for use (ifu), the user should: ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter agains t resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ 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: 10372836
• MDR Text Key: 202949837
• Report Number: 2029214-2020-00775
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: PED2-400-25
• Device Catalogue Number: PED2-400-25
• Device Lot Number: B002380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 70