MAUDE Adverse Event Report: MEDINOL LTD. X-SUIT NIR COVERED BILIARY METALLIC STENT; BILIARY, STENT

Model Number	10 X 60 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not yet returned to the manufacturer.
Event or Problem Description
The stent was broken in half after it was deployed at the lower middle bile duct and the broken stent in side of the duodenum was fallen in the duodenum.The customer was deployed a new stent into the stent which remained into the bile duct.There was no injury to the patient.The condition of the patient is ok.
Additional Manufacturer Narrative
The complaint was initially submitted as involving medinol's 510(k) cleared biliary product, the x-suit nir biliary metallic stent (k150487).On january 10, 2018, the product arrived at medinol for investigation.The investigation revealed that the complaint product is in fact a different biliary product manufactured by medinol, the x-suit nir covered biliary metallic stent.The complaint xs102 was deleted, and a different complaint was opened in its place.The x-suit nir covered biliary metallic stent is not cleared by fda, and therefore is not commercially distributed in the us.As a result, medinol would like to retract the previous mdr, and inform fda that additional reports will not be provided.

• Brand Name: X-SUIT NIR COVERED BILIARY METALLIC STENT
• Common Device Name: BILIARY, STENT
• Manufacturer (Section D): MEDINOL LTD.; beck tech bldg; 8 hartom st.; jerusalem, 97775 08; IS 9777508
• MDR Report Key: 7147244
• Report Number: 3003084171-2017-00013
• Device Sequence Number: 1013908
• Product Code: FGE
• UDI-Device Identifier: 04953170270659
• UDI-Public: 04953170270659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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 Model Number: 10 X 60 MM
• Device Catalogue Number: SME-210P-10060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1