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

Model Number SXR06080L

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2015

Event Type  Injury  

Manufacturer Narrative

The actual device was not returned to the manufacturing facility for evaluation.Therefore, the investigation is based upon the user facility information and the evaluation of the retention sample of the involved product code/lot number combination.Visual inspection did not find any anomalies along the total length.Magnifying inspection of the sliding part, including the stent, did not find any anomalies on the stent strut.The length of the stent was confirmed to meet manufacturing specifications.The outside diameter of the sliding part, including the stent, was also confirmed to meet manufacturing specifications.A review of the device history record and the product released decision control sheet of the involved product/lot# combination confirmed that there were no indications of production related problems or any discrepancies in the inspection/test results.A search of the complaint file did not find any similar report with the involved product/lot# combination.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 available information, it is likely that a pulling force in the proximal direction was applied to the actual device while the involved stent was being deployed, resulting in the reported elongation on the deployed segment.The potential for such an event is addressed in the instructions-for-use with statements such as the following: (1) "failure to maintain a fixed delivery catheter position or constraining the delivery catheter during deployment may result in stent compression (shortening) or elongation." (b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4) - it was reported that the stent looked potentially elongated, elongation of the stent is labeled in the ifu.Actual device not returned.

Event Description

The user facility reported that during an sfa case, when the misago device was deployed, it looked potentially elongated.Follow up communication with the user facility reported the following information: (1) access was gained at the femoral artery contralateral; (2) the physician started to pull back on the delivery system prior to completion of stent deployment; (3) the physician continued to deploy by clicking the thumbwheel as the system was being removed; (4) the physician noted when the case was completed that the stent looked elongated but could not confirm under flouro; (5) it was then decided to use a viabahn covered stent; (6) the stent was deployed throughout the entire lesion within all stents that were deployed previously; (7) the final run was taken and the physician was satisfied with the results; (8) the procedure was completed successfully; and (9) there was no patient injury.

Manufacturer Narrative

This report is being submitted as follow-up # 1 to provide a correction to sections.Please see these sections for updated information.During the manufacturers self-review of the description of this complaint, it was found that this event should be classified into "serious injury".All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Type of Device: STENT
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 5213191
• MDR Text Key: 30844385
• Report Number: 9681834-2015-00241
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04987350722102
• UDI-Public: (01)04987350722102(17)180331(10)150415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/14/2015,11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: SXR06080L
• Device Catalogue Number: SX*FXA0680LN
• Device Lot Number: 150415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/12/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2015
• Date Manufacturer Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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): Other