MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 10/25/2022

Event Type  malfunction  

Manufacturer Narrative

Explanted date: device was not explanted.Initial reporter occupation: cath lab rn.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number combination confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the misago stent involved would not deploy.The operator deployed the stent femoral; however, the outer blue sleeve was held which prevented the stent from deploying.The stent was removed, and a new one was used without holding the sleeve; it deployed successfully.The event occurred intra-operative.There was no patient injury/medical or surgical intervention.The procedure outcome was successful.Additional information was received on 01 nov 2022: the procedure performed was a lower extremity (le) angiography.There was no reported damage to the sheath prior to use.The patient was in stable condition.Additional information was received on 03 nov 2022: other equipment was used with the stent during procedure; however, it was femoral access, and the physician usually uses glidewire advantage and destinations.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.Visual inspection of the actual sample found that the stent had been deployed approximately 12 mm from the distal end of the stent sheath.Also, rippling of the distal shaft section was observed approximately 300 mm - 450 mm from the distal end.Magnifying inspection of the catheter shaft section found no deformation such as an elongation or crush.Magnifying inspection of the distal tip section found no crush or other anomaly in the appearance.Next, electron microscopic inspection of the same section found abrasions.Magnifying inspection of the stent sheath section found no deformity such as a crush.The release-wire fixing section was compared with the same section of a current product sample under a magnifier and confirmed to have no anomaly such as detachment.X-ray fluoroscopic inspection of the deployment handle found that the release wire had been wound around the thumbwheel in a regular circle.No anomaly was observed.X-ray fluoroscopic inspection of the catheter found no anomaly such as a breakage in the release wire.The release wire inside the rippled part of the catheter shaft had no anomaly such as a breakage or kink.The actual sample was deployed under warm water at 37°c.No resistance was felt during clicking and the actual sample was deployed successfully.Next, magnifying inspection of the deployed stent found no anomaly in the appearance such as a deformation of or breakage in the struts.Magnifying inspection of the area where the stent had been mounted found that the radiopaque marker at the proximal side had peeled and migrated to the proximal side.No external anomaly was observed in other parts.The stent sheath was separated from the main body and inspected under an electron microscopic inspection.Abrasions and roughness were observed on the surface.Most of the abrasions had occurred in the distal side of the stent sheath.Based on the above investigation results, it was presumed that the thumbwheel was clicked while the actual sample was in a trapped state by some kind of hard object (calcification).As a result, the sliding part was obstructed from moving proximally, which resulted in the reported event.In this case, it was assumed that the deployment handle was grasped, and the thumbwheel was clicked while the stent sheath was in a trapped state by some kind of hard object (calcification).As a result, the sliding part was obstructed from moving proximally, which resulted in the reported event.Based on this assumption, the following reproduction test was performed.In a simulated lower limb vascular model, a contralateral approach was made with a factory-retained destination 6fr 45cm, and the distal end was positioned at the iliac.After that, a misago sample from the involved product code was inserted along a 0.035" guidewire advantage.Then the distal side of the stent sheath and the mock vessel were pinched together by forceps in order to simulate a trapped-by-calcification state.Clicking of the thumbwheel was started.At seven clicks, the clicking became heavy, preventing the stent sheath from moving, and compressive force was applied to the part of the shaft that located outside the patient and rippling occurred.Continued clicking increased the difficulty in clicking, and the rippling of the shaft outside the patient progressed.The stent did not deploy.No further click was possible after 23 click as the deployment handle was hard, therefore the test sample was removed from the system.It should be noted that there is a possibility that the progression of rippling can be suppressed by gripping the proximal shaft section.As for the involved product type, if no load is applied to the sliding part, the stent will begin to expand after 10 to 15 clicks.The shaft section of the test sample was rippled as was the actual sample.It was inferred that the rippled portion was stretched during removal, and the rippled part of the proximal shaft was slightly released, so that the stent sheath gradually moved toward the proximal side, and the stent came out from the distal end.Therefore, the condition of the test sample was considered to be similar to that of the actual sample.According to the results of the investigation, since abrasions were found on the distal section of the stent sheath and the distal tip sections, it was thought that these sections were trapped by some kind of hard object (e.G., calcified lesion).Due to this, the sheath (sliding part) was prevented from moving proximally during deployment of the stent, which resulted in the failure of the stent to expand at a normal clicking count (10-15 clicks).At that time, the shaft section was exposed to compressing force and rippled, and insufficient gripping of the shaft (non­sliding part) was considered to have contributed to the rippling also.As for the stent having been deployed partially, it was thought that after the actual sample was removed from the destination, the rippling of the distal shaft section was slightly released, causing the stent sheath to gradually move and the stent to partially exit from the distal end.As a cause of the detachment of the radiopaque marker, it is thought that the proximal end of the stent came into strong contact with the radiopaque marker due to the stent sheath having been prevented from moving proximally, and the force in the proximal direction was applied to the radiopaque marker.It was indicated that the blue shaft (non-sliding part) was grasped when the event occurred, however, please be noted that the blue part is the proper part to grasp during stent deployment as indicated in the instructions for use (ifu) as follows."[directions for use] 3-6 to maintain the position of the delivery catheter while rotating the thumbwheel, grip the delivery catheter by hand at the operator side (proximal) of the intermediate shaft an d do not move the delivery catheter at the operator side of the intermediate shaft." for future use, please refer to the following information stated in the instructions for use (ifu)."[directions for use 4-3] as a guide, stent deployment commences on rolling back the thumbwheel 5-10 clicks for stents up to 100 mm long and 10-15 clicks for stents at least 120 mm long.Carefully roll back the thumbwheel one click at a time and adjust the position of the stent just prior to deployment if necessary (otherwise the stent can be deployed in the wrong position)." "deploy the stent completely, even if the delivery catheter bends and corrugates." "if the stent does not start to deploy when the thumbwheel is rolled back, if no corrugations can be seen in the delivery catheter, stop rolling the thumbwheel, observe using high­resolution fluoroscopy, and then carefully remove the stent system.(the stent system could become unrecoverable.)" "[precautions] to assure optimal stent delivery, confirm that the pre-dilation is properly done before stenting patients who have highly tortuous or calcified lesions and/or vessels proximal to the lesion." ashitaka factory manufacturing process has been making efforts in maintaining the quality of the product by performing following inspections.After the assembling, 100% visual inspection is performed to confirm there are no kinks or crushes in the sliding part or the shaft section.After the assembling, 100% inspection of stent release resistance is performed to assure no anomaly.

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15834960
• MDR Text Key: 307806867
• Report Number: 9681834-2022-00236
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04987350727787
• UDI-Public: 04987350727787
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: SXR07150R
• Device Lot Number: 200904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2020
• 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