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

Model Number N/A

Device Problems Positioning Failure (1158); Difficult to Insert (1316); Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2023

Event Type  Injury  

Manufacturer Narrative

Udi: n/a as this product code is not exported to the us market.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.Review of the manufacturing record and the shipping inspection record of the product with the involved product code/lot number confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report of the product with the involved product code/lot number from other facilities.Based on the circumstances of occurrence, as a possible cause of this case, the following mechanism was inferred.However, since the actual sample was not returned, the cause of occurrence could not be clarified.When the pci was performed after stenting the actual product, the guidewire was threaded into the stent strut of the stent which was placed in an overlapped position with the actual product.The dilator was inserted through the guidewire.The inserted dilator hit the stent strut of the stent, which was placed in an overlapped position, elongated the stent strut, and moved to aorta.At that time, the actual stent was pulled and elongated as well, and displaced.Relevant instructions for use (ifu) reference: care should be given when additional devices and wires are delivered through a previously placed stent in order to prevent damage or dislodgement.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).

Event Description

The user facility reported that a left femoral approach was selected for a percutaneous coronary intervention (pci) in left circumflex artery (lcx) - chronic total occlusion (cto) lesions.The involved misago 9.0/40 and 7.0/80 were placed in the common iliac artery (cia) - external iliac artery (eia) in left iliac.Although it was presumed, radifocus wire stiff type was threaded into the stent strut of the misago 9.0/40.Then, when inserting the dilator of an 8fr 40cm sheath (medikit), the dilator hit the misago 9.0/40, elongated the stent and was displaced to the aorta (the distal of stent was barely crimped to the cia opening).Since misago 9.0/40 and 7.0/80 were placed in an overlapped position, the misago 7.0/80 was pulled by the misago 9.0/40 and displaced to the central side while elongating the stent.After completing the pci, an attempt was made to dilate the metacross 8.0/40 in the stent of the misago 9.0/40 to put it back to its original position.However, since the misago 7.0/80 on the distal side was already displaced to the central side, it was not possible to put back.Since the stent of the misago 7.0/80 was elongated and the strut was partially rough, a smart 8.0/100 was placed in the stent.In the misago 9.0/40, all sections other than the distal of stent protruded into the aorta.However, since no countermeasures were found, progress was observed.A computed tomography (ct) was taken later.Although a small amount of blood clot was observed in the stent strut protruding to aorta, the patient's condition was good.The event occurred intra-operative.No device parts remained in the patient's body.The patient's final impact was remission.A competitor's stent was placed to cover the involved misago part.

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16493305
• MDR Text Key: 310784816
• Report Number: 9681834-2023-00032
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: SX-LMA0780RN
• Device Lot Number: 201027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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: 8FR 40CM SHEATH (MEDIKIT); RADIFOCUS WIRE STIFF TYPE
• Patient Outcome(s): Other