MAUDE Adverse Event Report: MICROVENTION, INC. HELICAL-10; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number 100730HCSR-R-V-CN

Device Problems Break (1069); Stretched (1601)

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

Event Date 09/16/2022

Event Type  malfunction  

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 device was returned to the manufacturer for analysis; however, investigation is not complete and still ongoing.A supplemental report will be provided upon completion of device evaluation.

Event Description

It was reported that during an aneurysm embolization procedure, the aneurysm was filled with multiple coils.When the 7x30 coil was used, the position of the coil filling was not ideal, and the physician adjusted positioning many times.When being removed, the coil stretched and a broke into two parts with distal part embedded in the coil mass.The other part was removed successfully.Another coil of the same model was used to complete the case.There was no report of harm or injury to the patient.

Manufacturer Narrative

Additional information: h6, h10 (summary device evaluation).Summary device evaluation: the investigation of the returned coil system found the implant severely stretched with the monofilament exposed and separated from the pusher.The stretched condition is consistent with the coil becoming stuck or experiencing friction during repositioning within the target site (i.E., stuck on previously implanted coils or the tip of the microcatheter).The pusher's heater coil showed no signs of activation using a detachment controller.The investigation found the implant¿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 separate from the pusher.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.

• Brand Name: HELICAL-10
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 15810392
• MDR Text Key: 307769416
• Report Number: 2032493-2022-00527
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050954
• 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
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100730HCSR-R-V-CN
• Device Lot Number: 2106255VL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/25/2021
• 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
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 64 KG