MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-475-35

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

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

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; however, return is anticipated.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information that during treatment of an aneurysm the "coil distal segment" of the device wasn't displayed under fluoroscopy and the distal position in the artery was lost.It was reported that this occurred while introducing the device through the microcatheter.It was further reported that the physician removed the device from within the microcatheter and upon removal from the patient, the physician pushed the device forward and it came out "without the distal coil" no patient injury was reported.

Manufacturer Narrative

Additional information received.Updated sections.The device has been returned and device evaluation is anticipated.A follow up supplemental will be submitted upon completion.

Event Description

Medtronic received additional information that the tip coil distal segment detached.The distal tip segment appeared outside the patient after removing the entire system.

Manufacturer Narrative

Type of follow up - device evaluation.Device evaluated by manufacturer- additional information the pipeline flex delivery system was returned with the microcatheter for evaluation without the pipeline device.The pushwire was found to be separated at the proximal to the proximal dps restraint.In addition, the tip coil, distal/proximal restraints and dps sleeves were found to be missing from the pushwire.The catheter lumen was flushed several times, but no missing distal segment was found.The distal hypotube was also found to be stretched with the ptfe shrink tubing still intact.The pushwire was observed to be bent 32.0 cm from the proximal end.No other anomalies were observed.The broken end was then pushwire was sent out for further sem analysis.Based on the analysis findings the clinical observation was confirmed as the received pipeline flex delivery system was found to be separated at the proximal to the proximal dps restraint.Based on the sem analysis, the fracture surface features of the broken end are consistent with torsional overload failure.The damages seen on the distal wire, hypotube and catheter suggests the delivery system was being pulled against resistance.However the cause for the resistance could not be determined.Per our instructions for use (ifu): ¿discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.¿ 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.

Manufacturer Narrative

Information received from the same report as mfr: 2029214-2016-00395.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5472551
• MDR Text Key: 39422528
• Report Number: 2029214-2016-00129
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: EC
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/04/2018
• Device Model Number: PED-475-35
• Device Catalogue Number: PED-475-35
• Device Lot Number: A037029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2015
• 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