MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR FLOW DISRUPTION DEVICE

Model Number MV-WB060421

Device Problem Device Dislodged or Dislocated (2923)

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

Event Type  Injury  

Event Description

It was reported that a web device was implanted in an acom aneurysm and a portion of it protruded into the parent vessel.A stent was implanted to address this protruding portion.The patient's status was stated to be "non-serious health damage.The patient has not recovered yet." it is unclear as to what the "non-serious health damage" was and what caused it.

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 implanted in the patient and was not available for return to the manufacturer for analysis.Medical imaging was not provided.Therefore, the reported event could not be confirmed.Attempts are being made to obtain more information about the patient's status and its relatedness to the device.If further information is obtained, a supplemental mdr will be submitted.

Manufacturer Narrative

H6 - add code 4624 and 4642 to health effect - impact codes.H6 - add code 3331 to type of investigation.H6 - remove code 10 from type of investigation.

Manufacturer Narrative

Additional information obtained via email stated that the "non-serious health damage" was the complaint itself: the web protruding into the parent vessel.The patient has recovered.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14190465
• MDR Text Key: 290304866
• Report Number: 2032493-2022-00177
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 04987892122347
• UDI-Public: (01)04987892122347(11)200910(17)230831(10)20091011C
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: MV-WB060421
• Device Lot Number: 20091011C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 06/01/2022; 06/01/2022
• Supplement Dates FDA Received: 05/03/2022; 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• 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 Outcome(s): Required Intervention