MAUDE Adverse Event Report: MICROVENTION, INC WEB SL 21 SINGLE LAYER; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number W4-6-4-CN

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/18/2023

Event Type  malfunction  

Event Description

As reported, the right bifurcation of the brain was planned.When flushing device, the physician found small particles inside the sphere of the web.For safety reasons, it was replaced with w4-6-3.There was no patient involvement.Procedure completed with alternate, and the patient is reported to be fine.

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 ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Manufacturer Narrative

Investigation findings items returned for evaluation: delivery system (pusher), web implant, introducer, dispenser hoop.Items not returned for evaluation: microcatheter, controller.The web implant was returned still attached to the pusher for analysis and was returned unsheathed.Upon inspection of the returned items, the web implant was found to be within visual and dimensional specifications (spec: diameter(mm)= 6.0 ± 0.6, height(mm)= 4.0 ± 0.4).However, the hypotube was observed to be kinked at the hypotube-to-connector junction.Further inspection revealed the presence of a loose particulate within the web implant.The loose particulate was extracted from the web implant for further analysis; however, the particulate was dropped during this process.Despite a thorough search of the work area, the attempt to locate the particulate proved unsuccessful; therefore, material identification could not be performed on the particulate to determine its origin.Investigation conclusion the investigation of the returned web system found the hypotube kinked at the hypotube-to-connector junction, and a loose particulate within the web implant, which is consistent with the alleged product issue.The loose particulate was extracted from the web implant for further analysis; however, the particulate was dropped during this process.Despite a thorough search of the work area, the attempt to locate the particulate proved unsuccessful; therefore, material identification could not be performed on the particulate to determine its origin.Based on the event description, the physician observed the particulate in the web implant during the flushing process.Per the web ifu, the microcatheter is flushed prior to the insertion of the web device; therefore, it is unlikely that the particulate would have originated from the lumen of the microcatheter.As the particulate would have been observed in the web implant prior to insertion in the microcatheter, it is possible the particulate was introduced in the web implant during the manufacturing process.The physical evaluation of the device could not identify the conditions or circumstances that led to the hypotube damage, but the damage is consistent with the device experiencing forces over specification.

Event Description

No additional information was received, please see h6 & h11.

• Brand Name: WEB SL 21 SINGLE LAYER
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18049566
• MDR Text Key: 327093429
• Report Number: 2032493-2023-01022
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429113776
• UDI-Public: (01)00842429113776(11)211209(17)251130(10)0000132519
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2023

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 Model Number: W4-6-4-CN
• Device Lot Number: 0000132519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 50 KG