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

Model Number PED2-350-14

Device Problems Break (1069); Unintended Ejection (1234)

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

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Medtronic received a report that the pipeline prematurely opened.The patient was undergoing surgery for treatment of an unruptured aneurysm in the paraophthalmic.It was noted the patient's vessel tortuosity was normal.Dual antiplatelet treatment was administered.The pru level is unknown.The angiographic result post procedure was successful.It was reported that the physician deployed pipeline in the ica.The  dr.Did not think his initial deployment was aligned correctly and went to resheath the device into the phenom 27 in accordance to the ifu.However, during this process, it appeared as if the device fell off of the resheathing pad.The physician felt as if the safest approach was to remove the phenom 27 with the device partially captured and to complete the case with a new phenom 27 as well as a new pipeline shield of the same size.Deployment was a technical success and the patient is doing well.The pipeline was not used for an indication that is off-label.The pipeline device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a q-apel medical guide catheter (fg220927e-02 sf7072-095-27-30 )/ 95 cm select flex ii 072 armadillo, and aristotle 24 soft guidewire (ga3501 lot#220916) .Additional information received that it was clarified that the pipeline prematurely detached inside the phenom 27.The pipeline separated from the pushwire.The pushwire was not rotated or pulled back at anytime during the procedure.

Manufacturer Narrative

H3: product analysis: #(b)(6) equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5), in-house 0.0260in mandrel, document used: dwgsfg15xxx-yyyy-zz rev.F, as found condition: the pipeline flex shield was returned stuck inside the phenom 27 catheter; within the outer carton; inside of a sealed bio-hazard bag and a shipping box., damage location details: the distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The pushwire appeared to be separated at proximal to the dps sleeves.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The distal and proximal ends of the braid were found fully opened and frayed.No bend was observed on the pushwire.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The catheter tip and marker were examined; no damages were found.The catheter body was found to be accordion at 4.6cm to 13.4cm from the distal tip.The broken end sent out for sem analysis.No other anomalies were observed.Testing/analysis: the pipeline flex shield could not be pushed forward or removed.The catheter was cut to remove the pipeline flex shield.The catheter total and usable length were measured within specifications.The catheter was flushed with water and found patent.The catheter was then tested by running an in-house 0.0260¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub with no issues; however, resistance was observed at the damaged locations.Per sem results: the broken end failed via ductile overload.Conclusion: based on the returned devices, the customer complaint was confirmed as the returned pipeline flex shield was stuck inside the phenom 27 catheter.In addition, the pushwire separated at proximal to the dps sleeves.Per the sem results, the broken end failed via ductile overload.Additionally, from the damages seen on the catheter (accordioning), braid (fraying), pushwire (separating), and hypotube (stretching); it appears there was high force used.It is possibly these damages occurred when the customer attempted to advance/resheath the pipeline flex shield through the catheter against resistance.However, the cause of resistance could not be determined.Possible cause of resistance includes lack of continuous flush during delivery.Ls 2023-07-06.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
• 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: 16930444
• MDR Text Key: 315308226
• Report Number: 2029214-2023-00793
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00763000284152
• UDI-Public: 00763000284152
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED2-350-14
• Device Catalogue Number: PED2-350-14
• Device Lot Number: B321117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2022
• 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: 31 YR
• Patient Sex: Female