MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FA-77475-20

Device Problems Break (1069); Kinked (1339); Device Damaged by Another Device (2915)

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

Event Date 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation; 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.

Event Description

Medtronic received information that prior to treatment of an aneurysm, the microcatheter was in place and the physician found the "push rod" was fractured upon opening the package.A new device was used to complete the procedure.No patient injury was reported.

Manufacturer Narrative

The device's pushwire was returned for evaluation.The device's braid was not returned.The pushwire within the capture coil were observed to be bent.No damages were found on the tip coil, capture coil, and proximal bumper.The coating of the entire pushwire length was examined was found to be damage at the proximal end.No other anomalies were observed.Based on the analysis findings and the reported event details, the report of fracture could not be confirmed.The device¿s pushwire was not found to be ¿fractured¿.The pushwire was observed to be damaged (bent) within its capture coil.The cause for the damage could not be determined.The coating damage on the pushwire appeared to have been caused by mechanical scraping and abrasion by a metal torque device (pin vise) and/or rhv valve.The torque device and rhv were also not returned for evaluation; therefore, any contributing factors from the torque device/rhv valve could not be determined.All products are 100% inspected for damage and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 5755634
• MDR Text Key: 48357081
• Report Number: 2029214-2016-00464
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S004
• 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: 07/14/2017

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: 01/26/2018
• Device Model Number: FA-77475-20
• Device Lot Number: A049089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2016
• Initial Date FDA Received: 06/28/2016
• Supplement Dates Manufacturer Received: 07/14/2017; 07/14/2017
• Supplement Dates FDA Received: 07/21/2017; 09/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR