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

Model Number PED2-500-12

Device Problem Activation Failure (3270)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

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 there was no opening of the pipeline possible in the proximal, middle, and distal segments due to very difficult anatomy. There was only short opening in the very distal part. The stent was positioned in a bend, more than 50% had been deployed, resheathing was performed more than twice, and no additional steps were taken in an attempt to open the stent. The phenom 27 catheter could not be used with the new stent due to high manipulation during the first use. Replacement products were used to complete the procedure. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Post-procedure angiography showed a modified thrombolysis in cerebral infarction (mtici) score of 3. The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm of the left internal carotid artery. It was noted the patient's vessel tortuosity was severe. Dual antiplatelet therapy (dapt) was administered. Ancillary devices include a cook shuttle 6f 80cm, stryker synchro 0. 014¿.

Manufacturer Narrative

H3: analysis of the pipeline flex shield (lot no. A822941) found that the distal and proximal dps restraints were 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. The distal and proximal ends of the pipeline flex shield braid were fully opened and moderately frayed. In addition, the middle section of the braid appeared to be fully opened with no damage. No bend found on the pusher. No damages were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper. No damage was found with the catheter. No other anomalies were observed. Based on the returned device, the pipeline flex shield was not confirmed to have "failure to open" issue as the distal and proximal ends of pipeline flex braid were fully opened and moderately frayed. In addition, the middle section of the braid appeared to be fully opened with no damage. The damage to the braid on the ends of the pipeline flex shield braid is likely the results of the physician re-sheathing the device more than re commended two times. It is likely that the severe vessel tortuosity may have contributed to the failure to open issue. Per our instructions for use (ifu): ¿begin to deliver the device using a combination of unsheathing the pipeline flex shield embolization device and pushing delivery wire simultaneously. After the distal end of the pipeline flex shield embolization device has successfully expanded, deploy the remainder of pipeline flex shield embolization device by pushing the delivery wire and/or unsheathing the pipeline flex shield embolization device. Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex shield embolization device. The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex shield embolization device. Re-sheathing the pipeline flex shield embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid. 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. ¿ h6: method code updated to b01. Result code updated to c070601. Conclusion code updated to d1103. 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

No additional information received.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10813264
• Report Number: 2029214-2020-01107
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/29/2022
• Device Model Number: PED2-500-12
• Device Catalogue Number: PED2-500-12
• Device Lot Number: A822941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial