MAUDE Adverse Event Report: MICROVENTION, INC. AZUR SOFT3D DETACHABLE 10; VASCULAR EMBOLIZATION DEVICE

Model Number MV-HS00520

Device Problem Fracture (1260)

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

Event Date 09/14/2022

Event Type  Injury  

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 stated to be available for analysis but has not yet been returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc.Will perform an investigation and will submit a supplemental mdr.The instructions for use (ifu) identifies coil misplacement premature coil detachment as a potential complication associated with use of the device.

Event Description

The product reported in this event is an exported device not cleared or approved for marketing in the u.S.The complaint is being reported based on this product meeting similar product criteria.It was reported during treatment in a segment of a vessel (1.5 mm in diameter) in the lateral thoracic artery, the coil encountered resistance and became stuck.While attempting to retract the coil it stretched.A snare device was delivered over the pusher, and it could not reach a desired position where it could capture the entire coil.Upon removal, the coil was severed, and a portion of the stretched coil was able to be removed from the patient.Multiple attempts were made for the remaining stretched coil to retract it into the angiographic catheter, to push it into the target site, or to flush and reposition it for removal from the patient, but all failed.The procedure ended by leaving the stretched portion of the coil in the patient, extending from the aorta and the descending aorta.The health damage to the patient was non-serious.Surgical intervention to remove the coil is planned; however, no details are currently available.

Manufacturer Narrative

Additional information indicating the coil remained in the lateral thoracic artery was removed by nonsurgical intervention.During removal, the coil severed in front of the brachiocephalic artery.A portion of the severed coil was removed successfully.While attempting to remove the remaining, the snare was entangled with the remaining portion of the coil.The snare was replaced with another snare to continue the procedure.Some portion remained in the internal thoracic artery, however, since this was the site originally being embolized, the procedure was ended judging that the remaining portion of the coil was not a problem.The removed coils were discarded.The patient outcome reported that there were no problems immediately after the procedure.The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Manufacturer Narrative

Summary device evaluation: imaging from the procedure was provided and reviewed as part of this investigation; a plain radiograph (no contrast material) centered over the right upper chest.A coil is seen in what is presumed to be the right lateral thoracic artery (from the event report), which has a vertical course.Intact coil is seen in the vertical segment.Superiorly, just before the artery takes a horizontal course (at its junction with the axillary/subclavian artery) the density of the coil decreases significantly, indicating that it is stretched/unraveled.The stretched coil extends to the junction of the brachiocephalic trunk with the transverse aorta.The more proximal part of the coil cannot be located as it is off the image.A microcatheter/snare combination is seen in the proximal subclavian artery.Vertically oriented packed coils are seen in a vessel on the patient's left, in a segment that crosses at least six ribs; according to the event report, these are from a prior embolization.The cause of the coil stretching cannot be determined from this single image.The investigation of the returned coil system found the pusher to be stretched at the distal section with the lead wires and the monofilament exposed, the proximal section of the severed implant to be severely stretched with the monofilament exposed and separated from the pusher.The distal portion of the severed implant was not returned for evaluation as it remained in the patient as described in the reported event.The implant's monofilament showed 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.This 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 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.

• Brand Name: AZUR SOFT3D DETACHABLE 10
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• 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: 15534684
• MDR Text Key: 301095982
• Report Number: 2032493-2022-00382
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 04987892128431
• UDI-Public: (01)04987892128431(11)220518(17)270430(10)0000196008
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-HS00520
• Device Lot Number: 0000196008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 6 MO
• Patient Sex: Female