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

Model Number PED-500-20

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6). The pipeline flex embolization device (model: ped-500-20 lot: a868568) (pli-10), and marksman catheter (model: fa-55150-1030 lot: 218155355) (pli-20) were returned for analysis. The pipeline flex embolization device was returned stuck within marksman catheter. (pli-20) upon visual inspection, no damages were found with the marksman hub or distal tip; however, the pipeline flex pushwire was found extending ~57. 5cm from the distal tip. No bends or kinks were found with the marksman catheter body. No damages were found with the distal tip. The marksman total length was measured to be ~158. 6cm. The marksman useable length was measured to be ~151. 0cm which is within specification. In order to remove the pipeline flex delivery system from the marksman catheter the catheter was dissected (cut), and the delivery system was then able to be removed. The marksman micro catheter could not be used for resistance testing with an in-house mandrel due to its damaged condition. (pli-10) during the removal of pipeline flex device the tip coil was inadvertently broken. No bends or kinks were found with the pipeline flex pushwire. The pipeline flex embolization device was found be broken at distal end of hypotube. The ptfe shrink tubing was found to be pulled back. The proximal bumper, pad and re-sheathing marker were found intact. The dps restraints/sleeves were found to be missing. The proximal and distal ends of braid were found to be collap sed and frayed. The broken distal hypotube was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis. The elemental analysis of the broken hypotube end shows elevated chlorine (cl), iron (fe), tin (sn), chromium (cr), and oxygen (o) peaks were detected on the wire surface, the fracture surfaces exhibit corrosion damage and surface contamination. The features observed are indicative of a combination of tensile and torsional overload failure mechanisms. No other anomalies were observed. Based on the device analysis and reported information, the customer¿s report of ¿resistance/stuck during delivery¿ was confirmed. The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary. Based on the investigation conducted resistance can occur during tracking, deployment and re-sheathing of the device in distal and tortuous anatomies. In addition, resistance can occur due to patient vessel tortuosity, failure to maintain a continuous flush, or pipeline is pulled back/torqued during delivery. The vessel anatomy was moderate in tortuosity and a continuous flush was maintained. Therefore, the cause could not be determined. 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. Based on the analysis findings, the customer report of ¿resistance/stuck during delivery¿ was confirmed. The returned pipeline flex device damages (broken hypotube) are indicative of high force used. It is likely the damage occurred when the customer attempted to advance the pipeline flex through the marksman catheter against the reported resistance. Possible contributors for resistance are patient vessel tortuosity or lack of continuous flush during delivery. Based on the returned devices, there was no non-conformance to specifications iden tified that led to the resistance during delivery issues. The investigation determined that this event was similar to events that had already been investigated, and another investigation is not necessary. Based on the formal investigation conducted, pushwire separ ation occurred due to a combination of tensile and torsional overload. Resistance can occur due to use of incompatible catheter, vessel tortuosity, failure to maintain continuous flush. If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a resistance between a pipeline device in a marksman catheter. The patient was being treated for an unruptured saccular aneurysm of a segment of an ophthalmic artery. The aneurysm max diameter was 18. 9mm and the neck diameter was 9. 2mm. Vessel tortuosity was moderate. It was reported that the pipeline couldnot be pushed out of the marksman catheter. The devices had been prepared and used according to the manufacturer instructions for use (ifu). The catheter was flushed per ifu. The devices were replaced to continue to the procedure. There was no harm or injury to the patient.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10545152
• Report Number: 2029214-2020-00939
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00847536019720
• UDI-Public: 00847536019720
• 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: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/21/2022
• Device Model Number: PED-500-20
• Device Catalogue Number: PED-500-20
• Device Lot Number: A868568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial