MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-325-16

Device Problem Difficult to Remove (1528)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 09/13/2017

Event Type  malfunction  

Event Description

Pt had a pipeline embolization of intracranial aneurysm.After confirming the working projections for pipeline deployment, a 3.25 x 16 mm pipeline embolization device was advanced, which was deployed from the proximal right mi segment of the right middle cerebral artery to the cavernous periophthalmic segment of the right internal carotid artery.Deployment of the pipeline was straight forward as the device opened up nicely by the usual pushing motion entirely covering the aneurysm.Once the device was fully deployed, it was attempted to readvance the microcatheter through the pipeline device over the delivery wire to retrieve the capture coil in the mca; however, because of significant tortuosity of the cavernous ophthalmic segment, this was impossible.They then removed the wire and the microcatheter together.However, upon attempting to pull back the wire, the capture coil was retained.They decided to snare the capture coil, which was retained at the superior m2 division of the right middle cerebral artery.Through the navien intermediate catheter and using roadmap technique, they advanced an xt-27 flex microcatheter over synchro-2 standard microwire and gently advanced to systems through the pipeline into the right mca near the proximal portion of the capture coil.After this microwire was removed and through the xt-27 microcatheter, they advanced a 2 mm of micro snare and tried to capture, the capture coil was difficult.They advanced the microcatheter at distal tip of the capture coil and snare it from distal to proximal.They then advanced the snare device, snared the capture coil and pulled it back.The retrieval motion was smoothed until they got the cavernous portion proximal to the pipeline where the device got stuck at tip of the navien but they managed to pull it back into navien.It appears that some unravelled material of the pusher retained in the cervical carotid artery segment.This was extremely tiny and not flow limiting or causing stenosis.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; irvine CA
• MDR Report Key: 6935625
• MDR Text Key: 89374850
• Report Number: MW5072655
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Model Number: PED-325-16
• Device Lot Number: A210313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2017
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 55