MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA MISAGO RX SELF-EXPANDING PERIPHERAL STENT

Catalog Number	SX-FXA0760LN
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned to the manufacturing facility for evaluation.Visual inspection upon receipt found a kink on the proximal shaft near the guide wire port.The stent was not in place.Magnifying inspection of the inner shaft where the stent had been crimped find no anomalies.Magnifying inspection of the sliding part revealed no anomalies.Magnifying inspection of the distal tip found some abrasions generated on its surface.Magnifying inspection of the segment where the traction wires are fixed found no anomalies.The outside diameter of the sliding part was confirmed to meet manufacturing specifications.X-ray fluoroscopic inspection of the inside of the deployment handle found that the thumbwheel had been clicked 35 times.A review of the device history record and the shipping inspection record of the involved product/lot# combination confirmed that there were no indications of production related problems.A review of the complaint history files confirmed that the involved product/lot# combination has not been reported previously.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined based on the investigation result, it was evident that the actual sample was subjected to a pulling force.As a result, it is probable that the deployed segment of the stent protruding from the distal end of the destination became caught in the distal edge of the destination.Continued pulling back of the misago could have caused the stent which had deployed inside the destination to become stretched.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: (1) ensure that the stent is not positioned within the introducer sheath, guiding sheath or guiding catheter.(2) eliminate any slack in the delivery catheter and fix in position.(3) do not pull the delivery system tight during stent deployment.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported that the misago device deployed inside of the destination device.Follow up communication with the user facility confirmed the following information: during deployment of the misago stent it started to drift proximally from the initial position; the device was move back into the involved destination and deployed; the stent was stretched to approximately 100mm possibly due to some pulling force to the misago device; the stent was left implanted in the patient; the procedure was completed; and the patient was not impacted.

• Brand Name: MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Common Device Name: STENT
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 5453529
• Report Number: 9681834-2016-00019
• Device Sequence Number: 279613
• Product Code: NIP
• UDI-Device Identifier: 04987350722188
• UDI-Public: 04987350722188
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/23/2016

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: 05/31/2018
• Device Catalogue Number: SX-FXA0760LN
• Device Lot Number: 150618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2016
• Initial Report FDA Received Date: 02/23/2016
• 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: DESTINATION; DESTINATION