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

Model Number PED2-425-20

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 06/18/2018

Event Type  malfunction  

Manufacturer Narrative

No device return so no product analysis could be performed.The cause of the event was not determined.D.Suspect medical device brand name: pipeline flex with shield technology model number: ped2-425-20 mdrs related to this event: 2029214-2018-00622, 2029214-2018-00623, 2029214-2018-00624.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during deployment of a pipeline product, the device would not open in the middle section.The pipeline devices were not used off-label and were prepared according to their indications for use (ifu).The product was also noted to have been manipulated normally while the middle section of the device was being deployed around a bend.The accessory products included the following: 6fr shuttle sheath, 5fr sophia.It was also confirmed that the patient's anatomy was normal.It was reported that upon deployment of a pipeline stent for a right internal carotid artery (ica) blister / unruptured aneurism, the product did not open more than 50% in the middle section.It was also noted that the product was twisted and flattened out.The product was re-sheathed twice and deployed again without success.The pipeline device was removed from the patient and it was discovered that it was "jammed in the marksman" catheter.Two addition pipeline devices and marksman guide catheters were used but the same issue occurred.An lvis jrn product was then inserted and removed as the event recurred again.There was no known impact or consequence to the patient.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

The pipeline flex with shield delivery system stuck inside the marksman catheter was returned for evaluation within its inner pouch; inside of a sealed bio-hazard bag and a shipping box.For further examination, the pipeline flex with shield was then pushed out from the catheter lumen with difficulty.A minimal amount of blood was observed inside the catheter lumen.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The outer diameter (o.D) of the re-sheathing pad was measured within specifications (0.5836mm).The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pipeline flex shield braid was found fully opened with moderately frayed at both ends.The pushwire appeared to be bent at 25.5 cm from the proximal end.No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip and the marker band were examined and no damages were found.The catheter body was found to be stretched and accordioned at 18.0 cm to 29.5 cm from the distal tip.No flash or voids molded were observed in the hub.The catheter was flushed with water and found to be patent.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel could pass through the catheter tip and hub with no issues; however, resistance was observed at the damaged locations.No other anomalies were observed.See related regulatory report 2029214-2018-00622.If information is provided in the future, a supplemental report will be issued.

Event Description

It was also confirmed that the patient's anatomy was normal and that all three of the pipeline devices acted in the same manner.Upon reflecting on the issue the physician felt the issue had nothing to do with the devices and more likely the anatomy of the vessel.It is believed that there may have been tissue webbing at the point of flattening, but this was unable to be proven.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 7690507
• MDR Text Key: 114558767
• Report Number: 2029214-2018-00623
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2020
• Device Model Number: PED2-425-20
• Device Catalogue Number: PED2-425-20
• Device Lot Number: A518691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2017
• 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: 55 YR