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

Catalog Number	SXR08080R
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted explanted date: device was not explanted.Initial reporter occupation- rt.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A cine image was provided by the user facility.Review of the cine image revealed that deformation (crushing or alike) on the tip side of the implanted stent.Normally, the length of the implanted stent and the distance between the radiopaque markers should be equal as a picture of a current product shows; however, from the cine image, it was observed that the length of the implanted stent was shorter than the distance between the contrast markers.Therefore, it was conceivable that the length of the stent had become shorter than normal.Product structure/cause of stent shortening.The stent is designed to self-expand by turning the thumbwheel (spooling the release wire connected to the sliding part) and retracting the sliding part to the proximal side.Therefore, if a stent release is performed with the sliding part of the delivery catheter trapped, and at the same time, if the force with which the sliding part is trapped is greater than the force with which the sliding part is pulled toward the proximal side, the non-sliding part (handle) will move forward and the inner tube and stent will move forward accordingly.As a result, the stent will expand in an area anterior to the target site.It is presumed that the shortening of the stent in this case was caused by this mechanism.A review of the device history record and shipping inspection record of the involved product code/lot# combination was conducted with no findings.Ifu states: do not use in highly tortuous or highly calcified lesions and/or vessels proximal to the lesion which could prevent proper pre-dilatation.Securely fix the delivery catheter so that it does not get drawn forward.(the stent can be compressed if the delivery catheter is drawn forward in reaction to resistance on the sliding part from vessel occlusion or tortuosity.) it is likely that the implanted stent might have been deformed (crushed) in the calcified area of the lesion.As for the shortening of the stent, from the structure of the product, it was inferred that the stent release was performed while the sliding part of the delivery catheter was trapped, causing the inner tube and stent to move forward.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.Please see mdr (b)(4) for the importer report.(b)(4).
Event or Problem Description
The user facility reported that the misago was used during the procedure.During an up and over peripheral intervention 6fr right sided access.When the stent was deployed in the left external iliac artery, it was noticed that the distal portion appeared irregular and crimped.It was relined with an 8x100 misago stent and the runoff appeared fine.The procedure was completed.The patient's condition was stable.There was no patient injury, medical/surgical intervention required.The artery was not previously treated.The left limb was diseased.The lesion length was approximately 60mm.The diameter stenosis was 80 percent.The approximate vessel diameter was 7mm.The location was other external iliac.The calcification was moderate.The tortuousness was mild.The site of access was femoral artery contralateral via antegrade.Lesion treatment history: both pre and post dilation.Additional information was received on 09apr2021.There was no injury to the patient.Additional information was received on 15apr2021.The distal end of the stent was irregular and crimped.An additional misago was placed to cover the damaged part.

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 11738043
• Report Number: 9681834-2021-00070
• Device Sequence Number: 11868923
• Product Code: NIP
• UDI-Device Identifier: 04987350727688
• UDI-Public: 04987350727688
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P140002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: SXR08080R
• Device Lot Number: 190131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 60