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	Unspecified Infection (1930)
Date of Event	09/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 (b)(6) 2016 that a wallflex" biliary rx fully uncovered stent was implanted during a stent placement procedure performed on (b)(6) 2016 as part of (b)(6).A baseline assessment of biliary obstructive symptoms was conducted and the following symptoms were reported: dark urine, pale stools, and jaundice.The patient's baseline karnofsky score was reported as 90, and the patient's weight was reported to be (b)(6).Baseline liver function tests were taken on (b)(6) 2016.The patient underwent pancreatic protocol computed tomography (ct), endoscopic ultrasound (eus), chest x-ray, and eus fine needle aspiration (fna), and a stage iia  t3 -n0 m0, a 4.3 cm adenocarcinoma tumor was identified at the head and body of the pancreas.On (b)(6) 2016, the patient underwent study stent placement as an outpatient procedure.A sphincterotomy was performed during this procedure, and the 10mm x 40mm wallflex biliary uncovered stent was placed in a satisfactory manner.On (b)(6) 2016, the patient experienced a serious adverse event of cholangitis.According to the complainant, the event is related to the study stent and was noted to be severe.On (b)(6) 2016, stent occlusion due to overgrowth was noted.A biliary reintervention was conducted and plastic stents were implanted.The patient was hospitalized from (b)(6) 2016 until (b)(6) 2016 and the cholangitis has been resolved.On (b)(6) 2016, the patient underwent curative intent surgery.No further adverse events have been reported.
Additional Manufacturer Narrative
Has been updated with additional information received on (b)(6) 2018.Has been updated with corrected information received on (b)(6) 2018.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2016 that a wallflex¿ biliary rx fully uncovered stent was implanted during a stent placement procedure performed on (b)(6) 2016 as part of the e7034 wallflex biliary preop drainage natx clinical trial.A baseline assessment of biliary obstructive symptoms was conducted and the following symptoms were reported: dark urine, pale stools, and jaundice.The patient's baseline karnofsky score was reported as 90, and the patient's weight was reported to be 98 kg.Baseline liver function tests were taken on (b)(6) 2016 (see block b6).The patient underwent pancreatic protocol computed tomography (ct), endoscopic ultrasound (eus), chest x-ray, and eus fine needle aspiration (fna), and a stage iia ¿ t3 -n0 m0, a 4.3 cm adenocarcinoma tumor was identified at the head and body of the pancreas.On (b)(6) 2016, the patient underwent study stent placement as an outpatient procedure.A sphincterotomy was performed during this procedure, and the 10mm x 40mm wallflex biliary unovered stent was placed in a satisfactory manner.On (b)(6) 2016, the patient experienced a serious adverse event of cholangitis.According to the complainant, the event is related to the study stent and was noted to be severe.On (b)(6) 2016, stent occlusion due to overgrowth was noted.A biliary reintervention was conducted and plastic stents were implanted.The patient was hospitalized from (b)(6) 2016 until (b)(6) 2016 and the cholangitis has been resolved.On (b)(6) 2016, the patient underwent curative intent surgery no further adverse events have been reported.Additional information received on (b)(6) 2018 the clinical site updated the onset date of the stent occlusion due to overgrowth from (b)(6) 2016, to (b)(6) 2016.According to the site, the stent was still functional.The overgrowth was reported to be related to the patient¿s cholangitis (onset date: (b)(6) 2016.

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6110595
• Report Number: 3005099803-2016-03493
• Device Sequence Number: 16253492
• Product Code: FGE
• UDI-Device Identifier: 08714729765332
• UDI-Public: (01)08714729765332(17)20171108(10)18610562
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Followup
• Report Date (Section B): 10/27/2016

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: Physician
• Device Expiration Date: 11/08/2017
• Device Model Number: M00570890
• Device Catalogue Number: 7089
• Device Lot Number: 18610562
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 11/17/2016
• Supplement Report FDA Received Date: 04/11/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 98