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

Model Number	SX*FMA07X5RN
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: vascular team lead.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.A review of the device history record and the shipping inspection record of the product code/lot# combination was conducted with no findings.(b)(4).
Event or Problem Description
The user facility reported that the involved r2p misago was used during the procedure.The stent moved forward initially during deployment, and then bunched up in multiple spots during deployment.They were using it through a 6f 11cm pinnacle sheath with an antegrade approach to the sfa.The estimated blood loss was less than 250cc.There was no patient injury, medical/surgical intervention required.The patient's condition was stable.The procedure outcome was successful.The artery of the lower extremity was not previously treated.Lesion treatment history: diseased right limb; location: sfa; calcification: moderate; tortuousness: mild.Lesion length, diameter, stenosis %: lesion length approximately (mm)180; % diameter stenosis: 90; reference vessel diameter approximately (mm)6.Site of access/puncture and approach: femoral artery ipsilateral and retrograde.Lesion treatment history: pre-dilatation: yes, and post-dilatation: yes.
Additional 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.The actual sample was received for evaluation.Visual inspection of the actual sample revealed that the sheath on the sliding part had been pulled back completely.Magnifying inspection of the area where the stent had been mounted revealed no kink, no deformity or no other visible anomaly.Magnifying inspection of the joint part where two traction wires were fixed to the sheath confirmed that the joint part was not disjointed.The outer diameter of the sliding part was measured and confirmed to meet the manufacturer specifications.X-ray fluoroscopic inspection of the deployment handle revealed that the traction wires had been rolled back properly.Ifu states: p27 precaution.When adjusting the position of the stent, always advance the stent system first and then pull it back to position the stent.(the stent can become shortened or elongated during deployment due to flexure of the delivery catheter within the vessel.) p26 precautions.Eliminate any slack in the delivery catheter and fix in position.(the stent can become compressed or elongated during deployment.) do not hold the sliding part of the delivery catheter.(the stent can become compressed during deployment.) based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of normal product.It is likely that the stent was released while the sliding part of the delivery catheter was in the state of being trapped by some factor (calcification lesion, etc.); which caused the inner shaft and the stent to move forward resulting in the shrinkage of stent.However, the state of the deployed stent (cine image) could not be confirmed.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: 10566479
• Report Number: 9681834-2020-00187
• Device Sequence Number: 2605716
• Product Code: NIP
• UDI-Device Identifier: 04987350727787
• UDI-Public: 04987350727787
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: 07/31/2022
• Device Model Number: SX*FMA07X5RN
• Device Catalogue Number: SXR07150R
• Device Lot Number: 190819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/08/2020
• 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: .014 GRANDSLAM WIRE; 6F PINNACLE SHEATH; .014 GRANDSLAM WIRE; 6F PINNACLE SHEATH
• Patient Age: 66 YR
• Patient Weight: 75