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

Catalog Number	SXR08060R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings.(b)(4).
Event or Problem Description
The user facility reported that they pulled an 8mm by 60mm 200cm shaft misago stent for the procedure.The vessel was pre-dilatated with a 5mm by 100mm crostella otw balloon.They then put up the stent into position and deployed the device.The doctor commented that the stent seemed to be too long, however, they deployed it anyway.After deploying the device, he felt the stent was way too long and he put up a 7mm by 80mm metacross and the balloon was not long enough with one inflation to have the stent oppose the wall.They had to inflate the balloon again to fully deploy the stent.The doctor alleged that he felt the package and product was mislabeled.Additional information was received on 26nov2019.The misago stent was deployed in the iliacs.The patient was in good condition and was stable.The outcome of the procedure was successful.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that the distal section of the stent may have got caught by a stenosis while the stent was being released, subsequently, when the actual sample in that state was withdrawn, the stent may have been subjected to pulling force and got elongated.Since the actual sample has not been returned for evaluation, the exact cause of the reported event cannot be definitively determined based on the available information.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).
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide additional information in section b5.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
Additional information was received on 13dec2019.At the time of surgery and initial post op the patient was well.There has been no follow up since.

• 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: 9517145
• Report Number: 9681834-2019-00232
• Device Sequence Number: 19563966
• Product Code: NIP
• UDI-Device Identifier: 04987350722300
• UDI-Public: 04987350722300
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/24/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: SXR08060R
• Device Lot Number: 181130
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 12/13/2019; 12/13/2019
• Initial Report FDA Received Date: 12/24/2019
• Supplement Report FDA Received Date: 12/25/2019; 01/08/2020
• 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: CROSTELLA OTW BALLOON