MAUDE Adverse Event Report: SEQUENT MEDICAL, INC WEB SINGLE LAYER-USA W2-8-4FOR US; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number FGA15080-040

Device Problems Difficult to Remove (1528); Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for evaluation.The investigation is currently ongoing.The instructions for use (ifu) identifies premature device detachment and difficult device detachment as potential complications associated with the use of the device.

Event Description

It was reported that treatment was performed for a middle cerebral artery (mca) bifurcation aneurysm.After placement of the web in the aneurysm, the web did not detach after two (2) attempts.The web appeared to have detached with the third attempt; however, when the pusher wire and microcatheter were removed, the web was pulled out of the aneurysm and then detached in the internal carotid artery (ica).The web was removed from the ica with a stent retriever.There was no reported patient injury.The patient was reported to have no deficiencies the day after the procedure.

Manufacturer Narrative

The web implant was returned detached from the delivery system.The web was not notably damaged and the detachment zone did not display any abnormalities.A kink was observed at the epoxy joint between the hypotube and gold connectory.The rest of the delivery system and the distal tip did not display any notable damage.The connector solder joints appeared intact; however, resistance was measured at "ol." the microcatheter used was returned and had pinches 5 cm, 6 cm and a smashed segment from 8 cm to 9cm from the distal tip of the catheter.The returned wdc activates normally and can successfully detach a web.To examine heater coil of the delivery system, the system was intentionally broken at an area distal to the hypotube/gold connector junction, and the core wire was removed from the system.The pet of the heater coil had signs of heat damage, and a coil from the heater coil was hanging outside of the tip of the strain relief.The web most likely was detached by the web detachment controller (wdc), as indicated in the complaint description; however, evidence from the heater coil suggests that the web may have had some interactions with the distal coils that resulted in the web sticking to the pusher post wdc activation, but this cannot be confirmed with absolute certainty based on the physical evaluation of the device alone.The associated via microcatheter was also returned with some damaged segments, but it is unclear when the damage occurred or if the damage caused or contributed to the reported complaint.

• Brand Name: WEB SINGLE LAYER-USA W2-8-4FOR US
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): SEQUENT MEDICAL, INC; 11 a columbia; aliso viejo, ca
• MDR Report Key: 10312043
• MDR Text Key: 199979068
• Report Number: 2032493-2020-00174
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00856956005817
• UDI-Public: (01)00856956005817(11)190814(17)240830(10)19081425
• Combination Product (y/n): N
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FGA15080-040
• Device Catalogue Number: FGA15080-040
• Device Lot Number: 19081425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention