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

Model Number PED-350-14

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thromboembolism (2654)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

The pipeline flex embolization device (ped) braid remains implanted in the patient.The pipeline flex delivery system was not returned for evaluation, therefore, the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Mdrs related to this event: 2029214-2018-00084 2029214-2018-00085.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the patient had full middle cerebral artery stroke 2 days post flow diversion treatment using two pipeline flex embolization devices (ped).This report is regarding (b)(4), referred as the 2nd ped in the paragraphs below.The devices were used to treat a patient's previously twice coiled aneurysm located at a1 segment of the right anterior cerebral artery (aca).It measured 5mm in both max diameter and neck width, with residual filling of aneurysm neck.Landing zones artery sizes were 3.27mm distally and 3.5mm proximately.Patient vessel tortuosity was severe.It was reported the ped's were prepared following the instruction for use.The 1st ped was deployed into aca covering the neck of the aneurysm without any issue.At retrieval of the delivery system, the physician pulled the delivery wire down to the microcatheter.During the process, the ptfe sleeves of the delivery wire bumped the proximal end of the deployed ped braid.The ped braid moved and no longer covered the proximal end of the aneurysm neck.Therefore, the 2nd ped was deployed via the internal carotid artery telescoped inside the 1st ped.The physician had no issue placing the 2nd ped.In doing so, the 2nd ped braid covered m1 segment of the middle cerebral artery (mca).When this initial procedure was completed, the patient was found to be difficult to arouse from anesthesia and not moving left side of the body.Anesthesia was resumed on the patient for an angiogram.The images revealed the patient's right mca was slow to fill.There was no thrombus noted in the angiogram.The patient was treated with integrillin over the course of 3 hours.At the end of the treatment, the images showed adequate perfusion.The patient was transfer to icu intubated for sedation after the procedure.The sheath was also left in patient's groin to maintain access.On the day after the procedure, the patient responded to all neurological checks.Later on the same day, the nurse removed the sheath and applied a closure device at the patient's groin.Massive bleeding at the patient's groin area followed.The patient became hypotensive and required necessitation.Blood and fresh frozen plasm transfusions were given to the patient.The necessitation efforts were successful, but it was noted the patient did not respond well to neurological checks again.Angiographic image indicated the mca was slow to fill.The same protocol of integrillin was used to treat the patient.Post treatment angiography revealed adequate perfusion.On the next day, the patient was unable to move the left side of the body.The patient had a full right mca stroke.

• 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: 7241327
• MDR Text Key: 99072032
• Report Number: 2029214-2018-00084
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2020
• Device Model Number: PED-350-14
• Device Lot Number: A486752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Date Device Manufactured: 07/06/2017
• 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): Other; Required Intervention
• Patient Age: 55 YR