MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/01/2010

Event Type  Injury  

Manufacturer Narrative

Age at event: mean age.Sex: gender of majority of patients.Date of event: estimate from information included in content.Journal article: efficacy and patency of primary stenting for hepatic venous outflow obstruction after living donor liver transplantation.Joo yeon jang, ung bae jeon, jung hwan park, tae un kim, jun woo lee, chong woo chu and je ho ryu doi: 10.1177/0284185116637247.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Protege and complete se self-expanding(se) stents were used during a study to investigate the efficacy and patency of primary stenting for hepatic venous outflow obstruction after living donor liver transplantation.The study was ongoing from october 2010 until december 2013 with 21 patients receiving 26 stents in 25 vessels.Average patient age was 53 y/o (range 41-65) and gender was majority male.Selective hepatic venography and stent placement were performed from the right internal jugular vein in all patients.A 0.035" hydrophilic guide wire and a 5f catheter were used to select each hepatic vein.Primary stent placement was performed with various stents depending on the case including protege and complete se stents.The stents were 8¿16 mm in diameter and 3¿12 cm long.Procedures were considered an immediate technical success when the hepatic venogram revealed alleviation of the hepatic venous anastomotic stenosis with fluent flow of contrast medium through the hepatic venous anastomosis.11 days post-procedure, one patient died of spontaneous intracranial hematoma despite successful stent insertion.Other complications included stent migration during the procedure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6352518
• MDR Text Key: 68113332
• Report Number: 2183870-2017-00090
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: 01/27/2017
• Supplement Dates FDA Received: 09/29/2017
• 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
• Patient Age: 53 YR