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

Model Number PED-450-14

Device Problems Break (1069); Fracture (1260); Device Operates Differently Than Expected (2913)

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

Event Date 08/24/2017

Event Type  malfunction  

Event Description

Patient with l-ica supra-ophthalmic cerebral aneurysm.Intra-op fracture of pipeline device delivery wire, distal end.It fractured/broke into two pieces.Pipeline deployed proximal to aneurysm, with residual distal portion of delivery wire still present in patient s/p failed attempts at removal.Wire now crossing from distal l-ica through a-comm into r-ica distally.Used merit 3.2 fr.En-snare device to attempt to snare pipeline.Exchanged to amplatz 7mm microsnare kit.Threader 1.2mmx12mm pta balloon advanced over synchro 2 wire to pipeline system.Synchro wire out and ev3 marksman catheter and solitaire platinum device advanced as a unit.The 198 cm of 204 cm pipeline wire removed.Septer occlusion balloon advanced over syncro 2 guidewire - inflated trying to pull pipeline system back.The 4x8 trek balloon advanced over synchro 2 wire to pipeline.Inflations were unsuccessful.Used amplatz 4mm gooseneck system, specter xc 4x11 balloon.

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 9775 toledo way; irvine CA 92618
• MDR Report Key: 6841557
• MDR Text Key: 84643084
• Report Number: 6841557
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/23/2020
• Device Model Number: PED-450-14
• Device Catalogue Number: PED-450-14
• Device Lot Number: A465049
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 83