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

Model Number W2-10-7-MVE

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Activation Failure (3270)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

Additional information: phone number: (b)(6).The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural images were not provided for review; therefore, the alleged product issue cannot be confirmed.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.

Event Description

It was reported that a large, 2-week-old, ruptured aneurysm of the left middle cerebral artery was treated the a web device, which did not open at the proximal end during positioning attempts, appearing twisted.The web could not be resheathed and detached during an attempt to withdraw it.Multiple devices were used to push the web into the aneurysm, but about half of the web appeared to be unopened.The aneurysm was still filling.The patient exhibited weakness in the right arm.A mri was performed and minor infarcts were observed in the anterior cerebral artery region.The patient was extubated the day after the procedure and woke up without any neurological deficits.

Manufacturer Narrative

Additional information: h8.H10: additional information received indicating the patient was released after procedure and no further treatment performed.Patient recovered significantly and is pretty independent.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11904837
• MDR Text Key: 256279689
• Report Number: 2032493-2021-00195
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102954
• UDI-Public: (01)00842429102954(11)190806(17)220731(10)19080630
• Combination Product (y/n): N
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: W2-10-7-MVE
• Device Lot Number: 19080630
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR