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

Model Number PED-375-20

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

Patient Problems Fistula (1862); Perforation (2001)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

The reported device was discarded by the facility.Therefore, a product evaluation cannot be performed and the clinical experience cannot be conclusively determine.However, the patient's tortuosity vessel anatomy could be a contributing factor.Additional information has been requested.Should any new information be received, a supplement report will be filed.Linked mdr's 2029214-2017-01339 2029214-2017-01340 2029214-2017-01341 2029214-2017-01342.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 2 pipeline flex devices were stuck inside marksman catheters during delivery at a flow diversion procedure to treat a patient's cerebral aneurysm.The first set of pipeline flex and marksman catheter was used and removed from the patient after the physician could not deploy the pipeline.The second set of pipeline flex and marksman catheter was used to continue the flow diversion procedure.The microcatheter was placed distally to the aneurysm.During the delivery of the pipeline, friction was encountered.It was reported "the carotid artery was torn because of friction.".The patient had a 2cm tear at the vessel with carotid cavernous fistula.Coil implants were used for treatment.The scheduled aneurysm treatment was ceased.It was reported this patient had severe vessel tortuosity.It took "6 turns" to reach the target lesion.

Manufacturer Narrative

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

Event Description

Description in initial report: it was reported this patient had severe vessel tortuosity.It took "6 turns" to reach the target lesion.Corrected information: it was reported this patient had 6 severe vessel bends.The pipeline flex device did not reach the targeted lesion.

• Brand Name: PIPELINE FLEX
• 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 ; 9496801224
• MDR Report Key: 7107266
• MDR Text Key: 94481642
• Report Number: 2029214-2017-01342
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2019
• Device Model Number: PED-375-20
• Device Lot Number: A278741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2016
• 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 Outcome(s): Required Intervention