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

Model Number PED-350-25

Device Problems Break (1069); Physical Resistance (2578)

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

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation and device analysis is anticipated.A supplemental will be submitted upon completion.Suspect medical device brand name = pipeline flex w/shield technology model # = ped2-350-25.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.

Event Description

Medtronic received information that during treatment of an aneurysm, the distal segment of the pipeline pushwire broke off within the microcatheter.It was reported that the separation happened when the physician attempted to resheath the device.All devices were removed from the patient successfully.A new pipeline was used to complete the procedure.There was no patient injury reported.The patient had moderate vessel tortuosity.

Manufacturer Narrative

Suspect medical device brand name = pipeline flex w/shield technology model # = ped2-350-25 the device was returned for evaluation and the clinical observation could not be confirmed.As received the pipeline flex with shield delivery system was stuck within the distal segment of the microcatheter.During evaluation, the pipeline with shield delivery system was pushed out of from the catheter with difficulty and found intact.No separation was observed with the pushwire.The distal and proximal ends of the pipeline braid were found fully opened with slightly frayed.Additionally, the pushwire found bent at the proximal end.All other subassembly found normal.All products are 100% inspected for damage and irregularities during manufacture.It is possible that the reported moderate vessel tortuosity may have contributed to the high friction during resheathing; subsequently causing the pipeline flex with shield to become damaged.Additionally, it was reported that the physician continued to resheath the pipeline flex with shield despite of high friction.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 intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.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.

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: 6459065
• MDR Text Key: 71837453
• Report Number: 2029214-2017-00371
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2019
• Device Model Number: PED-350-25
• Device Lot Number: A349238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: Not provided; 04/28/2017
• Supplement Dates FDA Received: 05/26/2017; 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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 Age: 65 YR