MAUDE Adverse Event Report: SEQUENT MEDICAL, INC WEB SL 17 SINGLE LAYER W5-6-3; WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM

Model Number FG29060-030

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.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 for investigation and the investigation is currently underway.

Event Description

It was reported that a web device was being used to treat an aneurysm, but it would not detach from the delivery pusher.The pusher wire was retracted after detachment attempts appeared successful, but the web had not detached and moved a little bit out of the aneurysm.During the attempt to withdraw the web into the microcatheter, the web became invaginated and then detached in the aneurysm.The physician was satisfied with the placement of the web and it was ultimately left completely placed inside of the aneurysm.The result was good.There was no reported patient injury or intervention.The patient is reported to be doing okay.

Manufacturer Narrative

The customer provided a fluoroscopic image of the web device within the patient.No contrast is visible.As result, it is not possible to visualize the boundaries of vessels, the aneurysm being treated, or the relative position of the web device to the aforementioned structures.Invagination of the web device by the via cannot be seen on the provided image.As result, the image does not provide evidence to support the complaint.The web delivery system and wdc2 were returned for evaluation.Wdc2 testing: a new web from r&d inventory was successfully detached on the 1st attempt with the returned wdc2.The wdc2 was then disassembled and the contacts were inspected, the battery voltage was measured, and a visual inspection was performed.Everything was within specification.The data log was downloaded, and it confirmed that the wdc2 detachment during the case was correct in terms of voltage output.Also, the resistance of the web used in the case was within specification.Voltage output and duration were measured with the oscilloscope and values were within specification; the waveform looked normal.Web system: the returned web was evaluated and found that the delivery system resistance was within specification.The device was then cut in half and the overcoil was slid off from the delivery system distally so that the heater coil region could be examined.The distal winds of the heater coil were slightly stretched out, distal to the polyimide heat shield.It also appeared that some of the pet heat shrink tubing between the heater coil forward and back winds was also distal to the polyimide shield.Under a high-power microscope, the attachment tether was confirmed to be melted.There were no indications of a "partial melt." the reported complaint is non-verifiable.The pusher and detachment controller were the only components received for investigation, as the implant was implanted during the procedure.Since the implant is unavailable for this investigation, the analysis of the returned devices cannot confirm or unconfirm the conditions or circumstances that led to the reported event.The returned web detachment controller was found to function normally and within specification.The physical evaluation of the web delivery system found the pusher resistance to be within specification, and the tether was found to be melted, which indicates a proper thermal detachment.The heater coil's distal winding was found to be slightly stretched, which may indicate the implant's tether experienced some friction with the heater coil on the pusher.

• Brand Name: WEB SL 17 SINGLE LAYER W5-6-3
• Type of Device: WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM
• Manufacturer (Section D): SEQUENT MEDICAL, INC; 11 a columbia; aliso viejo CA 92656
• MDR Report Key: 9101388
• MDR Text Key: 191387417
• Report Number: 2032493-2019-00229
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00854111006310
• UDI-Public: (01)00854111006310(11)190514(17)220606(10)19051417
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/06/2022
• Device Model Number: FG29060-030
• Device Lot Number: 19051417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 50