MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX COIL SYSTEM (HYPERSOFT); NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 100152HS-V-N

Device Problems Break (1069); Stretched (1601); Component Missing (2306)

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

Event Date 01/19/2023

Event Type  malfunction  

Event Description

It was reported that during an embolization procedure, the coil was deployed but on angiographic imaging, no coil was evident.The microcatheter was removed and inspected but no coil was found.The procedure was completed using a new coil without injury or complications to the patient.Reportedly, the coil system was not inspected before use.

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The delivery system was reported available for return, but has not yet been returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed at this time.If the device or additional information is received, microvention will submit a supplemental report.

Manufacturer Narrative

Additional information: h6, h10 (summary device evaluation).Summary device evaluation: the reported missing implant complaint is unconfirmed.The investigation of the returned coil system found the implant coils to be severely stretched and broken at the proximal section.However, the implant was returned still attached to the pusher upon receipt.The distal portion of the implant was found to be severely stretched and tangled on the middle section of the pusher.The heater coil did not show signs of activation using a detachment controller.The implant¿s monofilament was found to experience a tensile break based on the profile of the tip, which is consistent with the severe stretching of the implant.The broken condition of the implant is consistent with the device experiencing excessive force that exceeded the device's tensile strength, resulting in the implant breaking.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 microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

Manufacturer Narrative

Correction: d10 (date device received): apr 3, 2023.

• Brand Name: MICROPLEX COIL SYSTEM (HYPERSOFT)
• Type of Device: NEUROVASCULAR EMBOLIZATION 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: 16401087
• MDR Text Key: 309994067
• Report Number: 2032493-2023-00577
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170019418
• UDI-Public: (01)00810170019418(11)190920(17)240831(10)1909205NH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100152HS-V-N
• Device Lot Number: 1909205NH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2019
• 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