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

Model Number PED-425-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

The device has been returned for evaluation and analysis of the device is anticipated.A supplemental report will be submitted upon completion.Mdrs related to this report: 2029214-2016-01124, 2029214-2016-01125, 2029214-2016-01126.

Event Description

Medtronic received information that during treatment of an aneurysm located in the right internal carotid artery (ica), a dissection, resulting in the placement of a stent, occurred within the right ica.Per the event report the dissection was likely a result of the number of passages made to deliver the device and the time of the procedure as the patient had severe vessel tortuosity.

Manufacturer Narrative

As received, the pipeline flex delivery system (ped-425-20) was returned stuck inside the distal segment of the microcatheter.The distal hypotube appeared to be stretched.The distal end of the pipeline braid was observed slightly frayed.The pushwire was found bent and kinked.The catheter body was found to have accordion damage.No other anomalies were observed.Based on the reported information and device analysis we are unable to definitively determine the cause for the reported experienced.However, it is possible that the ¿severe vessel tortuosity¿ may have contributed to ¿resistance¿ during delivery; subsequently causing the pipeline flex delivery system and the catheter to become damaged and stuck.However, the cause for resistance could not be determined.Additionally, the damages seen on the catheter body (accordioning), proximal wire (kinking/bending), pipeline braid (fraying) and hypotube (stretching); suggest excessive force was used.Furthermore, it was reported that the dissection of the right ica was likely a result of the number of attempts made to deliver the pipeline.We are unable to definitively determine the cause for the dissection.However dissection is listed as a potential complication in the pipeline flex ifu.Per our instructions for use (ifu), the user should: ¿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 intralumenal 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.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.¿ all products are 100% inspected for damage and irregularities during manufacture.

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: 6181616
• MDR Text Key: 62602125
• Report Number: 2029214-2016-01124
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2018
• Device Model Number: PED-425-20
• Device Lot Number: A102199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided; 01/17/2017
• Supplement Dates FDA Received: 02/03/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 60