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

Model Number	SX*FMA0640RN
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - requested, not provided, age & date of birth - requested, not provided, patient sex - requested, not provided, weight - requested, not provided, ethnicity - requested, not provided, race - requested, not provided, implanted date: device was not implanted, explanted date: device was not explanted.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.For this reason, evaluation code 11 has been referenced in the conclusions.A review of the device history record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.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
The user facility reported that the involved r2p misago was used during the procedure.The physician noted need for an sfa stent during a lower extremity runoff.When tech was preparing to load r2p misago stent on to the wire they noted that the outer deployment sheath was pulled back slightly and the distal end of the r2p misago was exposed and was nearly beginning to deploy.The stent was not introduced into the body.A second stent was opened and used without issue.There was no patient complication, the case was completed without complication.The patient's condition was stable.There was no patient injury, medical/surgical intervention required.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, and to provide the completed investigation results.The actual sample was received for evaluation.Visual inspection revealed that that the stent had been dislocated from the catheter.The thumb wheel was found locked.Visual inspection of the stent revealed that it had been elongated; however, no break or no deficient part was confirmed.Magnifying inspection of the sliding part found a bent part at approximately 51 mm from the distal end and a buckled part at approximately 74 mm from the distal end.Based on the generation of buckling, it is likely that some compressing force in the proximal direction was applied to that area.The outer diameter was measured near the deformed sections and confirmed to meet the manufacturer control criteria.No anomaly in outer diameter was observed.X-ray fluoroscopic inspection of the handle revealed that the thumb wheel had not been rotated.Reproductive testing was performed with current product samples.The sliding part and the intermediate shaft were hold, and then the sliding part was pulled.As a result, the catheter shaft became curved; however, the sheath was not moved, the stent was not expanded.The distal tip and the sliding part were hold, and then the sliding part was pulled.As a result, sheath was moved, and the stent was expanded.Ifu states: if you see a gap between the sliding part tip and the catheter tip, move the sliding part to eliminate the gap.Stop using the stent system immediately if the gap cannot be eliminated by moving the sliding part.(this could cause adverse events, such as vessel damage.) based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the sheath might have been moved due to some factors and the stent might have self-expanded accordingly.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 10157477
• Report Number: 9681834-2020-00097
• Device Sequence Number: 11729312
• Product Code: NIP
• UDI-Device Identifier: 04987350727480
• UDI-Public: 04987350727480
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: 12/31/2021
• Device Model Number: SX*FMA0640RN
• Device Catalogue Number: SXR06040R
• Device Lot Number: 190109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 06/16/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1