MAUDE Adverse Event Report: MICROVENTION, INC MICROPLEX HYPERSOFT HELICAL; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number 100153HS-V-A2

Device Problems Difficult to Remove (1528); Stretched (1601); Separation Failure (2547)

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

Event Date 05/11/2022

Event Type  Injury  

Event Description

As reported, the physician situated the lvis jr 3.5x18 and inserted the coil to treat aca(rt) aneurysm.Every coil was used after conducted v-grip based on ifu.He had inserted hypersoft 3d 4x8, hypersoft 3d 3x8, hypersoft 3d 1.5x4 and hypersoft helical 1.5x3.The last coil failed to be detached.He changed the v-grip and tried to detach the coil several times, but still, he could not detach the coil.While he was retrieving the coil, the implant got stretched, so he pushed and crumpled the implant by using a micro snare.After that, he situated lvis 4.5x23 on the crumpled implant and put it on the vessel wall.There was no reported impact or harm to the patient.

Manufacturer Narrative

A search for non-conformance's 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 stated to be available for evaluation but has not yet been returned.If the device is received, the investigation will be performed, and a supplemental report will be submitted.

Manufacturer Narrative

The investigation of the returned coil system found the pusher's body coil damaged and stretched at distal, the pusher's hypotube bent at proximal, and the green and yellow lead wires broken at the distal solder joint.The implant was not returned for evaluation.No indication of using a detachment controller was found on the pusher's heater coil.The broken lead wires at the distal solder joint would have caused or contributed to the detachment issue observed during the procedure; furthermore, the radiographic images provided by the customer revealed that the implant was stretched and placed inside the patient, which is also consistent with the reported event.The investigation found the pusher's monofilament with a tensile break shape at the tip which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to stretch and separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher and lead wire damage, but the damage is consistent with the device experiencing forces over specification.

• Brand Name: MICROPLEX HYPERSOFT HELICAL
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14477983
• MDR Text Key: 293300212
• Report Number: 2032493-2022-00210
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777020550
• UDI-Public: (01)00816777020550(11)210922(17)260831(10)0000088662
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K091641
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100153HS-V-A2
• Device Lot Number: 0000088662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2021
• 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
• Treatment: HYPERSOFT 3D 1.5X4; HYPERSOFT 3D 3X8; HYPERSOFT 3D 4X8; LVIS 4.5X23; LVIS JR 3.5X18; V-GRIP
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 89 KG