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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Type  Injury  

Manufacturer Narrative

The device lot number was not provided; therefore, a device history record and non-conformances search could not be performed.The device remains implanted in the patient.The event as described cannot be confirmed.

Event Description

As reported through the article titled, "retreatment strategies in aneurysm woven endobridge recurrences: a case series" a patient presented with a history of hypertension and hyperlipidemia presented with a hunt & hess grade ii sah after having the worst headache of the patient's life.A ct of the head showed sah in the posterior fossa, and a cerebral angiogram confirmed a ruptured left 6.5 x 4.2mm posterior inferior cerebellar artery (pica) aneurysm.The aneurysm was embolized with a web sl device 6 x 3, and the patient did well.An initial angiographic result showed stasis of contrast with an o'kelly-marotta grade iii.A 9-month follow-up angiogram showed a 30% residual filling of the aneurysm at the neck with impaction of the inferior pole of the web device.The patient then had a flow diversion of the aneurysm with a pipeline stent.The final angiographic run showed a significant stasis within the aneurysm, which carried on to the late venous phase with no evidence of vascular cutoff.The patient did well and is scheduled for a 6-month follow-up mra and angiogram.The period of time reported for the cases and follow-up were 2015 through january 2021.

• Brand Name: WEB
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14049115
• MDR Text Key: 288877337
• Report Number: 2032493-2022-00130
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 67 YR
• Patient Sex: Male