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

Catalog Number	SXR06150R
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.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.Do not deploy the stent until it is properly positioned.(if the stent is deployed in an incorrect position, it may not expand fully).It is possible that the stent was released in a position deviated from the target lesion, which resulted in the collapse of the stent.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 6mm misago stent collapsed in the common iliac.They were under the impression the doctor was placing in the sfa.The physician had to put a vbx stent in its place.They did a cut down on the left groin and restent.The procedure was successful.The patient's condition was stable, and they went home.The artery of the lower extremity was not previously treated.Lesion: left diseased limb; location sfa popliteal other cia.Calcification was moderate.Tortuousness was mild.Vessel diameter approximately (6 mm).Access site: other axillary.Lesion treatment history: post-dilatation: yes; pre-dilation: no.Additional information was received on 19mar2021.It was a r2p case.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information.
Event or Problem Description
Additional information was received on 13apr2021.The doctor stated that it was not anything with the terumo sheath, he was trying to use a low-profile sheath and it was his decision.The misago, did not completely collapse, it buckled at the proximal end; the doctor said he should have used a larger size.Additional information was received on 16apr2021.There is no allegation against the reported product currently.

• 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: 11618819
• Report Number: 9681834-2021-00047
• Device Sequence Number: 11534558
• Product Code: NIP
• UDI-Device Identifier: 04987350727749
• UDI-Public: 04987350727749
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 06/30/2022
• Device Catalogue Number: SXR06150R
• Device Lot Number: 190711
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR SLENDER DESITNATION
• Outcome Attributed to Adverse Event: Required Intervention