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

Model Number PED2-400-16

Device Problems Break (1069); Retraction Problem (1536); Physical Resistance/Sticking (4012)

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

Event Date 04/02/2019

Event Type  malfunction  

Manufacturer Narrative

This is a report for a similar device that is not marketed in the us.Suspect medical device - similar device brand name = pipeline flex w/shield technology model # = ped2-400-16 the pipeline flex with shield device has not been returned for evaluation; product analysis cannot be performed.The device was not returned; therefore, the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that pipeline flex with shield device (ped2), distal tip coil and wigs separated from the pushwire.The patient was treated for a right internal carotid artery (ica) para-ophthalmic, unruptured, saccular aneurysm, with a max diameter of 5mm and a 4mm neck.The distal landing zone was 4mm and the proximal was 4mm.The anatomy was moderate in tortuosity.It was reported that after successfully deploying the ped2, the medtronic catheter was inserted back through the ped2 to recapture the distal tip coil and ptfe wings.The tip was engaged but difficulty was experienced when attempting to pull it back into the catheter when the distal tip coil and wings detached from the rest of the pusher wire.The catheter was carefully pulled out, and the detached tip coil and wings came with it.On the bench it could clearly be seen that it had detached from the wire.The post procedure angiographic result was good.There were no reports of patient injury in association with this event.

Manufacturer Narrative

At this time no conclusions can be made.The attorney alleges that the patient had subsequent surgical intervention;however no details have been provided.The cause of the patient postoperative complications cannot be determined at this time.No lot number has been provided therefore a review of the manufacturing records is not possible at this time.Information is limited.Should additional information be provided a supplemental emdr will be submitted.Note:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Addendum: this supplemental emdr is being sent to provide the correct product information for the perfix light plug.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

• Brand Name: PIPELINE FLEX W/SHIELD TECHNOLOGY
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8557565
• MDR Text Key: 143527819
• Report Number: 2029214-2019-00385
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2021
• Device Model Number: PED2-400-16
• Device Catalogue Number: PED2-400-16
• Device Lot Number: A704587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1