MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 100304HS-V-A2

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/23/2022

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance 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 is expected for return evaluation however, currently pending receipt.If the device is received for evaluation, upon completion of the investigation, a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

Event Description

It was reported that during treatment of a right acom aneurysm, during positioning of the embolization coil, the coil prematurely detached.A portion of the coil remained partially within the microcatheter and aneurysm.The entire coil was successfully withdrawn with the microcatheter.An additional coil was successfully deployed with good result.There was no reported patient injury or intervention performed.

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 investigation found the implant severely stretched and damaged with the monofilament broken and exposed.The pusher was not returned for evaluation; however, the monofilament remaining in the implant was found damaged.The monofilament experienced a tensile break based on the profile of the tip, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The stretched condition is consistent with the coil becoming stuck or experiencing friction during repositioning within the aneurysm (i.E.Stuck on previously implanted coils or the tip of the microcatheter).The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

• Brand Name: HYPERSOFT-AV
• Type of Device: NEUROVASCULAR EMBOLIZATION 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: 15533194
• MDR Text Key: 306352578
• Report Number: 2032493-2022-00386
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777024107
• UDI-Public: (01)00816777024107(11)201125(17)251031(10)2011255PH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131948
• 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
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100304HS-V-A2
• Device Lot Number: 2011255PH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2020
• 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 Age: 51 YR
• Patient Sex: Female