MAUDE Adverse Event Report: MICROVENTION, INC. AZUR SOFT3D DETACHABLE 10; PERIPHERAL

Model Number MV-HS00310

Device Problems Material Fragmentation (1261); Unraveled Material (1664); Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  Injury  

Event Description

It was reported after embolization of a coil at the right bronchial artery with six coils, the incident occurred when the right seventh costal artery was attempted to be embolized.The coil was attempted to be detached after placement at the target site (seventh intercostal artery) through a competitor microcatheter but could not be detached.When the coil was pulled back, the implant remained at the target site, and the pusher was withdrawn.The implant separated at the transition zone between the soft zone and the support zone of the pusher.The soft zone of the pusher, remained in the angiographic catheter (5fr, 100cm) and was checked under fluoroscopy to avoid cutting the pusher, and a cut was made in the proximal part of the microcatheter to insert a pta balloon, to retrieve the pusher.The pta balloon was inserted to fix the pusher, and the pusher was attempted to be withdrawn along with the angiographic catheter.As it was thought that the implant had not detached normally and was cut in the middle, a sheath was replaced with a larger sheath (8fr), and the stretched part of the implant of the coil floating in the aorta was entwined with a snare and retrieved from the puncture site.As the stretched implant was not visible under fluoroscopy, it was confirmed by ct.The ct showed that a portion of the implant attempted to embolize the seventh intercostal artery, was stretched and remained in the aorta for approximately 3cm.In addition, there were small implant fragments remaining in the right inferior femoral artery and left internal iliac artery, but the physician did not consider that this to be a clinical problem and determined to monitor the patient.The physician palpated the right and left ankles to check blood flow and determined that there was no problem.The patient was not in serious condition and recovered.

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 device was returned to the manufacturer for evaluation.Procedural notes or medical imaging were not provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.

Manufacturer Narrative

Investigation conclusion the investigation of the returned coil system found the pusher returned without the implant attached, but no indications of activation using a detachment controller was observed on the pusher heater coil.Further inspection found the pusher bodycoil stretched, damaged, and broken at the transition point.The pusher bodycoil was also found stretched at the middle section, and the hypotube was kinked at several locations.The implant was returned stretched, broken into pieces, and entangled with an orange-colored object observed in the middle of the implant.The orange-colored object is consistent with hydrogel that has absorbed blood from the procedure.The investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing 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.Due to the break condition of the returned pusher, this investigation could not test the continuity or resistance of the pusher to determine if a condition existed in the pusher electrical circuit that would have caused or contributed to the initial instance of non-detachment described in the reported event.The pusher was found with a clean, precise appearance at the site of the break, consistent with a cut.The event description states the physician checked the pusher under fluoroscopy to avoid cutting it, but as the pusher is made of stainless steel, which is not very visible under fluoroscopy, it may be possible the pusher was cut mistakenly during the procedure.However, as the returned angiographic catheter was found cut at a separate location proximal to the pusher transition break, and as the microcatheter used in the procedure was not returned for evaluation to verify the location of its cut and compare it to the location of the pusher break, this investigation had insufficient information to definitively determine the cause of the pusher's break condition.

• Brand Name: AZUR SOFT3D DETACHABLE 10
• Type of Device: PERIPHERAL
• 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: 17485565
• MDR Text Key: 320652248
• Report Number: 2032493-2023-00887
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 04987892128349
• UDI-Public: (01)04987892128349(11)221118(17)271031(10)0000289347
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161367
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-HS00310
• Device Lot Number: 0000289347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention