MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-375-35

Device Problem Unintended Ejection (1234)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis findings: the pipeline flex embolization device (model: ped-375-35 lot: a667361) was returned for analysis within a shipping box; within an opened pipeline flex embolization device outer carton; within an opened pipeline flex embolization device inner pouch and within a dispenser track.No bends or kinks were found with the pipeline flex pushwire.The pipeline flex embolization device was found be detached at distal end of hypotube.The proximal bumper, pad, pad restraint, dps sleeves and tip coil were found to be missing and not returned.The hypotube was found to be stretched and the ptfe pulled back.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿device opens prematurely¿ was unable to be confirmed as the distal end of pipeline flex device was already detached and not returned.Possible causes for ¿device opens prematurely¿ are resistance during delivery, high force delivery, or introducer sheath was not seated properly in hub of catheter.There was an indication that the event could be related to a potential manufacturing issue; therefore, a device history record review was performed.The lot history record of the reported lot number has been reviewed.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that while the physician tried to advance the pipeline inside the microcatheter, the pipeline got deployed inside it.The patient was undergoing surgery to treat an unruptured, amorphous aneurysm located at the internal carotid artery with a max diameter of 20mm and a neck diameter of 12mm.The distal landing zone was 3.2mm and the proximal landing zone was 4mm.It was noted the vessel tortuosity was moderate.There were no patient symptoms associated with the event.The devices were prepared as indicated in the ifu.Additional information received indicated the pushwire was not rotated or pulled back at any time during the procedure.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 11566655
• MDR Text Key: 242181550
• Report Number: 2029214-2021-00342
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00836462015784
• UDI-Public: 00836462015784
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/26/2021
• Device Model Number: PED-375-35
• Device Catalogue Number: PED-375-35
• Device Lot Number: A667361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 03/24/2021
• 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 Age: 31 YR