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

Model Number PED2-400-10

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

The device was implanted in the patient.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that 2 pipeline flex with shield (ped2) were used to treat a neck recurrence (2 x 3 x 3mm) of a ruptured and coiled pcoma-aneurysm (initially 8x5x4,5 mm).Catheterization of left ica with triaxial system (neuron max, navien 058, phenom 27, transcend platinum).Based on sim and cure calculations a 4 x 10 mm ped was chosen.Unproblematic initial unsheathing of the device in m1 segment (to release the petals) and re-sheathing.Correct positioning of ped2 in the ica terminus to over cover the neck of the aneurysm.Unsheathing of the device.However, re-sheathing of the delivery wire with the microcatheter proved to be difficult (the wire was aligned against the outer curve of cavernous ica) and was aborted.In the control run, there was distal shortening of the ped2 (pli10) was noticed ¿ resulting in insufficient aneurysm neck coverage.A second device of 4 x 12 mm ped (pli20) was delivered in the same manner, with a slightly distal landing zone.In the last run, there was enough neck coverage.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8744557
• MDR Text Key: 149654211
• Report Number: 2029214-2019-00633
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2019
• Device Model Number: PED2-400-10
• Device Catalogue Number: PED2-400-10
• Device Lot Number: A353334
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 73 YR