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

Model Number N/A

Device Problems Stretched (1601); Physical Resistance/Sticking (4012)

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

Event Date 10/18/2023

Event Type  Injury  

Event Description

The user facility reported that the procedure performed was a left radial approach with a slenguide to treat a stenotic lesion in left external iliac artery (eia).After predilation with sc balloon, the involved stent was implanted in the eia.While delivering a 6.0mmx40 balloon to post-dilate, resistance was felt.After the post dilation when the balloon was pulled out, the stent strut was partially elongated.Balloon-expandable bns was implanted additionally.The procedure was completed successfully.No medical or surgical intervention was required.The final patient impact was not harmed.

Manufacturer Narrative

A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D4: udi: n/a as this product code is not exported to the us market.D6b: explanted date: device was not explanted.The actual sample was discarded by the involved facility.Review of the manufacturing record and the shipping inspection record of 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.It was inferred that the balloon for post dilation was caught on the stent for some reason, and when the balloon in that caught state was pulled out, the stent was deformed.However, since the actual sample and cine image could not be confirmed, the cause of the occurrence could not be clarified.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.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• 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: 18091854
• MDR Text Key: 327620129
• Report Number: 9681834-2023-00216
• 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: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SX-LMA0740RN
• Device Lot Number: 230328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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
• Patient Outcome(s): Required Intervention