MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EU ENT4.5MMD 28MML WNO DSTL TP; INTRACRANIAL NEUROVASCULAR STENT

Model Number 641CX0202

Device Problem Material Separation (1562)

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

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported from a health authority that a patient underwent a vascular stent placement with an enterprise 4.5mm x 28mm vascular reconstruction device with no distal tip (enc452800/6920541), which experienced a fracture in the guidewire and broke during the procedure.Per the event description, under the guidance of a 0.035 super sliding guide wire and path, the 8f guide catheter (mpa1-cordis) and the head end of the intracranial support catheter was inserted into the petrous segment of the left internal carotid artery by coaxial technology.The m1 segment of the left middle cerebral artery was occluded by angiography, with an mtici of 0.The intracranial support catheter was gently and slowly placed at the m1 occlusion of the left middle cerebral artery.No blood flow was found, so it was connected to a negative pressure device for suction twice, but no thrombus was found.Considering the high possibility of atherosclerotic stenosis and occlusion, a 0.014-inch micro guide wire was selected, and with the help of a microcatheter and the guidance of a path map, the head end of the micro guide wire carefully crossed the occluded segment and was placed at the end of the m2 segment of the left middle cerebral artery.The head end of the micro guide wire followed up to the starting segment of m2, and the distal access catheter followed up to the starting segment of m1.The micro guide wire was withdrawn, and the true lumen was determined by angiography.A 0.014-inch micro guide wire was selected to be placed along the microcatheter at the end of the m2 segment of the left middle cerebral artery and the microcatheter was withdrawn.A percutaneous transluminal angioplasty (pta) balloon (0mm x 9mm) was placed in the occluded section along the micro guide wire and expanded twice, but after reexamination, it was noted that the occluded section was not opened.Another pta balloon (2.0mm x 15mm) was placed in the occluded section and expanded twice.After reexamination, it was noted that blood flow in the occluded section was recanalized, with an mtici of 2.However, after reexamination, it was noted that the blood vessels were once again occluded, and the recanalization could not be maintained.Another pta balloon (2.5mm x 15mm) was selected and expanded once, and upon reexamination, the angiography showed recanalization of the occluded segment, with an mtic of 2b and residual stenosis of about 50%.As a result, a stent system (4.5mm x 28mm) was selected to be placed along the micro guide wire at the stenosis segment of the left middle cerebral artery.After multi-position angiographies and ¿bony localizations¿, it was confirmed that the stenosis lesion was covered.The stent was slowly released, and the micro guide wire was withdrawn, but there was resistance.After slight twisting, the head end of the guide wire was about 10mm broken and hung onto the stent.The angiography showed that the residual stenosis was about 50% with an mtici score of 2b.The situation was discussed with the patient's family members; specifically, ¿that the guide wire of the stent is broken and hung in the stent¿.Also, how ¿difficult it is to capture and remove the broken piece of the guidewire, so it can be placed again¿.According to the event description provided ¿the support presses the broken guide wire between the supports or expands the support to fit the guide wire to the support as much as possible to prevent the guide wire from floating¿.As a result, a 0.014-inch micro guide wire was gently passed through the stent segment and placed in the m2 segment of the left middle cerebral artery.A pta balloon (2.5mm x 15mm) was placed in the stenotic segment and dilated once.Tirofiban 0.5mg was slowly injected into the intracranial support catheter.After reexamination, the angiography showed that the m1 segment of the left middle cerebral artery was unobstructed with an mtici of 2b, and the residual stenosis was about 40%.After ten (10) minutes of observation, the angiography showed that the recanalization of the stenosis remained stable, and the broken guide wire was covered on the upper end of the stent and fixed without floating.There was no bleeding or retention of the contrast agent seen on the xper ct, so the guide catheter was withdrawn, and the operation was concluded.Additional information was received on 06-jun-2022 indicating that the procedure was an emergency selective aortic arch via the femoral artery and cerebral angiography and interventional therapy.

Manufacturer Narrative

Product complaint #
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> (b)(6) updated sections on this medwatch: b4, g3, g6, h2, h6 and h10.The device remains implanted; therefore, no further investigation can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6920541.Indicating this product was final inspection tested at lake region medical and was determined to be acceptable.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint # (b)(4).Updated sections on this medwatch: b4, b5, g3, g6, h2, h10 and concomitant products.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information was again received on 11-jul-2022 indicating that the anonymized procedural films were unavailable.Excessive force was not applied to the device and the device was examined prior to use.The system was used with the recommended microcatheter, which was a prowler select plus (lot 30734760).There was no patient injury as a result of the device damage.There wasn¿t any vessel characteristic that may have contributed to the device malfunction.There wasn¿t any unusual resistance or friction encountered while advancing the stent through the concomitant microcatheter and the concomitant devices functioned as expected.There was a non-significant 30-minute procedural delay.Complaint conclusion: it was reported from a health authority that a patient underwent a vascular stent placement with an enterprise 4.5mm x 28mm vascular reconstruction device with no distal tip (enc452800/6920541), which experienced a fracture in the guidewire and broke during the procedure.Per the event description, under the guidance of a 0.035 super sliding guide wire and path, the 8f guide catheter (mpa1-cordis) and the head end of the intracranial support catheter was inserted into the petrous segment of the left internal carotid artery by coaxial technology.The m1 segment of the left middle cerebral artery was occluded by angiography, with an mtici of 0.The intracranial support catheter was gently and slowly placed at the m1 occlusion of the left middle cerebral artery.No blood flow was found, so it was connected to a negative pressure device for suction twice, but no thrombus was found.Considering the high possibility of atherosclerotic stenosis and occlusion, a 0.014-inch micro guide wire was selected, and with the help of a microcatheter and the guidance of a path map, the head end of the micro guide wire carefully crossed the occluded segment and was placed at the end of the m2 segment of the left middle cerebral artery.The head end of the micro guide wire followed up to the starting segment of m2, and the distal access catheter followed up to the starting segment of m1.The micro guide wire was withdrawn, and the true lumen was determined by angiography.A 0.014-inch micro guide wire was selected to be placed along the microcatheter at the end of the m2 segment of the left middle cerebral artery and the microcatheter was withdrawn.A percutaneous transluminal angioplasty (pta) balloon (0mm x 9mm) was placed in the occluded section along the micro guide wire and expanded twice, but after reexamination, it was noted that the occluded section was not opened.Another pta balloon (2.0mm x 15mm) was placed in the occluded section and expanded twice.After reexamination, it was noted that blood flow in the occluded section was recanalized, with an mtici of 2.However, after reexamination, it was noted that the blood vessels were once again occluded, and the recanalization could not be maintained.Another pta balloon (2.5mm x 15mm) was selected and expanded once, and upon reexamination, the angiography showed recanalization of the occluded segment, with an mtic of 2b and residual stenosis of about 50%.As a result, a stent system (4.5mm x 28mm) was selected to be placed along the micro guide wire at the stenosis segment of the left middle cerebral artery.After multi-position angiographies and ¿bony localizations¿, it was confirmed that the stenosis lesion was covered.The stent was slowly released, and the micro guide wire was withdrawn, but there was resistance.After slight twisting, the head end of the guide wire was about 10mm broken and hung onto the stent.The angiography showed that the residual stenosis was about 50% with an mtici score of 2b.The situation was discussed with the patient's family members; specifically, ¿that the guide wire of the stent is broken and hung in the stent¿.Also, how ¿difficult it is to capture and remove the broken piece of the guidewire, so it can be placed again¿.According to the event description provided ¿the support presses the broken guide wire between the supports or expands the support to fit the guide wire to the support as much as possible to prevent the guide wire from floating¿.As a result, a 0.014-inch micro guide wire was gently passed through the stent segment and placed in the m2 segment of the left middle cerebral artery.A pta balloon (2.5mm x 15mm) was placed in the stenotic segment and dilated once.Tirofiban 0.5mg was slowly injected into the intracranial support catheter.After reexamination, the angiography showed that the m1 segment of the left middle cerebral artery was unobstructed with an mtici of 2b, and the residual stenosis was about 40%.After ten (10) minutes of observation, the angiography showed that the recanalization of the stenosis remained stable, and the broken guide wire was covered on the upper end of the stent and fixed without floating.There was no bleeding or retention of the contrast agent seen on the xper ct, so the guide catheter was withdrawn, and the operation was concluded.Additional information was received indicating that the procedure was an emergency selective aortic arch via the femoral artery and cerebral angiography and interventional therapy.Additional information was again received on 11-jul-2022 indicating that the anonymized procedural films were unavailable.Excessive force was not applied to the device and the device was examined prior to use.The system was used with the recommended microcatheter, which was a prowler select plus (lot 30734760).There was no patient injury as a result of the device damage.There wasn¿t any vessel characteristic that may have contributed to the device malfunction.There wasn¿t any unusual resistance or friction encountered while advancing the stent through the concomitant microcatheter and the concomitant devices functioned as expected.There was a non-significant 30-minute procedural delay.The device remains implanted; therefore, no further investigation can be performed.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of the lot 6920541.Indicating this product was final inspection tested at lake region medical and was determined to be acceptable.Fracture of the delivery wire is a known potential complication associated with the use of the enterprise device and is listed in the instructions for use (ifu) as such.Since the event of delivery wire fracture required surgical intervention and medication to preclude permanent impairment of a body function or permanent damage to a body structure, the event meets mdr reporting criteria as a ¿serious injury¿.The file will be re-reviewed if additional information is received at a later date.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: EU ENT4.5MMD 28MML WNO DSTL TP
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14680668
• MDR Text Key: 294775502
• Report Number: 3008114965-2022-00426
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 10878528008894
• UDI-Public: 10878528008894
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Model Number: 641CX0202
• Device Catalogue Number: ENC452800
• Device Lot Number: 6920541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0.014-INCH MICRO GUIDE WIRE.; 0.035 SUPER SLIDING GUIDE WIRE.; 8F GUIDE CATHETER (MPA1-CORDIS).; INTRACRANIAL SUPPORT CATHETER.; PROWLER SELECT PLUS 150/5CM.; PTA BALLOON (0MM X 9MM).; PTA BALLOON (2.0MM X 15MM).; PTA BALLOON (2.5MM X 15MM).; UNSPECIFIED MICROCATHETER.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male