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

Model Number PED-350-10

Device Problem Activation Failure (3270)

Patient Problem Fistula (1862)

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

The pipeline flex will not be returned for evaluation as it was implanted in the patient.The report that the pipeline flex did not completely open could not be confirmed.The cause of the issue could not be determined from the reported information.The location of the vessel rupture is proximal to the location of the pipeline implant.Vessel perforation is a known inherent risk of endovascular procedure and are documented in the pipeline flex embolization device instruction for use.Same event as reported in mdr mfr: 2029214-2016-00312.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 report that a pipeline flex did not open during a procedure.In addition, the patient experienced a periprocedural vessel rupture.The patient was undergoing flow diversion treatment for an unruptured, saccular aneurysm.The aneurysm was located in the left internal carotid artery (ica) just proximal to the posterior communicating (pcom) artery.The aneurysm had a max diameter of 5mm and neck diameter of 2mm.Landing zone artery size was 3.4mm distal and proximal.Vessel tortuosity was normal.The devices were prepared as indicated in the ifu.A continuous heparinized saline flush was used during the procedure.It was reported that a pipeline flex was deployed around a bend in the vessel.Upon deployment, the proximal end was not apposed to the vessel wall.The pipeline flex was never resheathed.The physician used a hyperglide balloon to angioplasty the proximal end open.A regular 1ml syringe was used with 50/50 contrast.The hyperglide was inflated twice without any issue.At the third inflation, the balloon caused a small rupture in the cavernous section of the ica that resulted in a carotid cavernous fistula (ccf).No medical or surgical intervention was required at the time.It was reported that the physician will monitor the patient for symptoms and decide whether treatment is needed.There was no report of patient symptoms as a result of this event.Post-procedure angiographic result showed slowing of flow into the aneurysm, as expected.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: 5659703
• MDR Text Key: 45308644
• Report Number: 2029214-2016-00311
• 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,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2018
• Device Model Number: PED-350-10
• Device Lot Number: A105736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Date Device Manufactured: 05/13/2015
• 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): Other
• Patient Age: 55 YR
• Patient Weight: 99