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

Catalog Number SX-IMA0940RN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 05/28/2021

Event Type  Injury  

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: where post-dilatation is needed, use a dilatation catheter with a balloon shorter in length than the stent and an expansion diameter roughly consistent with the reference vessel diameter.After post-dilatation, perform angiography to confirm adequate expansion.Care should be given when additional devices and wires are delivered through a previously placed stent in order to prevent damage or dislodgement.According to the investigation results, no abnormality was found in the manufacturing and shipping inspection records.From the circumstances of the occurrence, it is not clear which device (the product in question or the devices used in combination) caused the vessel dissection; therefore, the cause of this incident could not be clarified.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the misago was used during the procedure.The stent in question was used for right eia.Glidesheath 7fr was inserted in left radial, cag was done, then r2p slen guide was advanced up to the front of the lesion, jupitar fc3 300 cm was crossed the lesion.Pre-dilation was done with senri 7.0 x 40, then the stent was placed and post-dilated with the same senri.After that, dissection was found at the distal side of the lesion.An additional r2p misago 8.0×40 was implanted.Because it is unknown when the vessel dissection occurred, in addition, there may be other causes such as wire manipulation, it has not been determined that the misago had an effect on the vessel dissection.The patient was not harmed.The procedure outcome was not reported.

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12106142
• MDR Text Key: 259592915
• Report Number: 9681834-2021-00119
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: SX-IMA0940RN
• Device Lot Number: 191029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: JUPITER FC3; R2P SLEN GUIDE; SENRI
• Patient Outcome(s): Required Intervention