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 Codes	Nausea (1970); Vomiting (2144); Jaundice (2187)
Date of Event	08/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).(b)(6) clinical trial.The complainant indicated that the device 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 december 06, 2016 that a wallflex biliary rx uncovered stent was implanted during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2015 as part of the (b)(6) clinical trial.The patient had a history of pancreatic cancer and a prior plastic biliary stent.The patient was enrolled in the study for treatment of malignant neoplasms with no intended surgery.On (b)(6) 2015, an assessment of biliary obstructive symptoms (abos) was taken and reported right upper quadrant pain.Liver function tests were also performed on (b)(6) 2015.The patient underwent an endoscopic retrograde cholangiopancreatography (ercp), magnetic resonance cholangiopancreatography (mrcp), ct scan and endoscopic ultrasound (eus) with fine needle aspiration (fna) for imaging/tissue sampling during the stent placement procedure on (b)(6) 2015.The procedure was done in an inpatient setting and a pancreatogram was performed during the procedure.Additionally, the plastic biliary stent was removed during the procedure.The study stent was implanted on (b)(6) 2015 in a satisfactory manner during the ercp.On (b)(6) 2016, the patient experienced right upper quadrant pain, jaundice, nausea and vomiting.According to the complainant, the study stent was noted to be occluded on (b)(6) 2016.The reason for the stent occlusion is unknown.A biliary intervention was performed at a different hospital from the study site and a new stent was implanted.There were no other associated adverse events reported.
Additional Manufacturer Narrative
Additional information received on (b)(6) 2017.The patient¿s biliary reintervention was performed at hopital (b)(6).
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2016 that a wallflex¿ biliary rx uncovered stent was implanted during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2015 as part of the e7099 abc wallflex registry clinical trial.The patient had a history of pancreatic cancer and a prior plastic biliary stent.The patient was enrolled in the study for treatment of malignant neoplasms with no intended surgery.On (b)(6) 2015, an assessment of biliary obstructive symptoms (abos) was taken and reported right upper quadrant pain.Liver function tests were also performed on (b)(6) 2015 (see block b6).The patient underwent an endoscopic retrograde cholangiopancreatography (ercp), magnetic resonance cholangiopancreatography (mrcp), ct scan and endoscopic ultrasound (eus) with fine needle aspiration (fna) for imaging/tissue sampling during the stent placement procedure on (b)(6) 2015.The procedure was done in an inpatient setting and a pancreatogram was performed during the procedure.Additionally, the plastic biliary stent was removed during the procedure.The study stent was implanted on (b)(6) 2015 in a satisfactory manner during the ercp.On (b)(6) 2016, the patient experienced right upper quadrant pain, jaundice, nausea and vomiting.According to the complainant, the study stent was noted to be occluded on (b)(6) 2016.The reason for the stent occlusion is unknown.A biliary intervention was performed at a different hospital from the study site and a new stent was implanted.There were no other associated adverse events reported.

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6210845
• Report Number: 3005099803-2016-03984
• Device Sequence Number: 866476
• Product Code: FGE
• UDI-Device Identifier: 08714729765332
• UDI-Public: (01)08714729765332(17)20170805(10)0018267974
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2016

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: Health Professional
• Device Expiration Date: 08/05/2017
• Device Model Number: M00570890
• Device Catalogue Number: 7089
• Device Lot Number: 0018267974
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 03/06/2017
• 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: 66 YR