MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ BILIARY RX STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570890
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event of stent blocked/occluded.(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on february 02, 2017 that a wallflex biliary uncovered stent was implanted on (b)(6) 2016 as part of the (b)(6) trial.The patient had a history of ampullary cancer and was enrolled into group b palliative treatment of biliary strictures produced by malignant neoplasms prior to curative intent surgery; with or without neoadjuvant therapy.On (b)(6) 2016, an assessment of biliary obstructive symptoms was taken and reported jaundice, itching, dark urine, and pale stools.Liver function test was taken on (b)(6) 2016.Imaging (ercp, ct, and eus) and tissue diagnosis using fine needle aspiration (fna) was with a result of malignant neoplasm that is deemed resectable.An endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure was performed on (b)(6) 2016.During the stent placement procedure, a pancreatogram and biliary sphincterotomy were performed, and the study stent was implanted in a satisfactory manner.On (b)(6) 2016, due to diseases progression, the patient was transitioned to palliative management and will not undergo curative intent surgery.On (b)(6) 2017, the study stent was noted to be occluded due to tissue ingrowth.Biliary obstructive symptoms were obtained and reported as right upper quadrant pain, jaundice, and itching.On (b)(6) 2017, a biliary reintervention was performed and a non-bsc stent was placed.The study stent remains implanted.Also on (b)(6) 2017, the patient had a trans-hepatic biliary drainage placed due to disease progression.On (b)(6) 2017, a non-bsc stent was placed and on (b)(6) 2017 the trans-hepatic biliary drain was removed.

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6361386
• Report Number: 3005099803-2017-00439
• Device Sequence Number: 10900539
• Product Code: FGE
• UDI-Device Identifier: 08714729765332
• UDI-Public: (01)08714729765332(17)20180110(10)0018789370
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140630
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2018
• Device Model Number: M00570890
• Device Catalogue Number: 7089
• Device Lot Number: 0018789370
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2017
• Initial Report FDA Received Date: 02/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR