MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	07/20/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E7034 wf biliary preop drainage natx clinical study.(b)(4).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, the supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018, that a wallflex biliary rx uncovered stent was implanted as part of the e7034 wallflex biliary pre-operative drainage neoadjuvant therapy registry clinical trial.The patient was enrolled into the clinical trial on (b)(6) 2015.According to the complainant, on (b)(6) 2015, baseline liver function tests were taken.Assessment of biliary obstructive symptoms (abos) was conducted and the following symptoms were reported: dark urine, pale stool, jaundice and itching.A 1.9 cm adenocarcinoma tumor was found in the head of the pancreas.On (b)(6) 2015 the patient underwent a study stent placement procedure as an outpatient.A biliary sphincterotomy was performed during the stent placement procedure and prophylactic antibiotics were administered.The 10mm x 80mm wallflex biliary rx uncovered stent was placed in a satisfactory manner.On (b)(6) 2015, the patient experienced acute cholecystitis and an ir guided percutaneous cholecystostomy tube was placed.The patient was hospitalized on (b)(6) 2015.On (b)(6) 2015, the event was considered resolved and the patient was discharged.On (b)(6) 2015, the patient underwent the curative intent surgery.Reportedly, the tumor was confirmed resectable.The patient underwent a whipple procedure and the study stent was removed en bloc during the surgery before resecting the tumor.
Additional Manufacturer Narrative
Event: event description has been updated with the additional information received on november 30, 2018.Date rec¿d by mfr: e7034 wf biliary preop drainage natx clinical study.Patient code 1932 (inflammation) captures the reportable event of acute cholecystitis.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.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, the supplemental medwatch will be filed.This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/26/2018 02:57 pm ct.The report number is being corrected from: 3005099803-2018-62183 to: 3005099803-2018-61076.
Event or Problem Description
It was reported to boston scientific corporation on october 05, 2018, that a wallflex biliary rx uncovered stent was implanted as part of the e7034 wallflex biliary pre-operative drainage neoadjuvant therapy registry clinical trial.The patient was enrolled into the clinical trial on (b)(6) 2015.According to the complainant, on (b)(6) 2015, baseline liver function tests were taken (please see relevant tests/laboratory data).Assessment of biliary obstructive symptoms (abos) was conducted and the following symptoms were reported: dark urine, pale stool, jaundice and itching.A 1.9 cm adenocarcinomic tumor was found in the head of the pancreas.On (b)(6) 2015, the patient underwent a study stent placement procedure as an outpatient.A biliary sphincterotomy was performed during the stent placement procedure and prophylactic antibiotics were administered.The 10mm x 80mm wallflex biliary rx uncovered stent was placed in a satisfactory manner.On (b)(6) 2015, the patient experienced acute cholecystitis and an ir guided percutaneous cholecystostomy tube was placed.The patient was hospitalized on (b)(6) 2015.On (b)(6) 2015, the event was considered resolved and the patient was discharged.On (b)(6) 2015, the patient underwent the curative intent surgery.Reportedly, the tumor was confirmed resectable.The patient underwent a whipple procedure and the study stent was removed en bloc during the surgery before resecting the tumor.Additional information received on november 30, 2018, the date of the patient's curative intent surgery was corrected to on (b)(6) 2015.According to the complainant, the curative intent surgery was complex due to inflammation around the portal hepatitis (site of bilioenteric anastomosis) secondary to acute cholecystitis and percutaneous gallbladder drain, which may have been caused by the 10mm x 80mm wallflex biliary rx uncovered stent.On (b)(6) 2015, an inpatient biliary reintervention was conducted wherein a drainage catheter was placed.It was reported that the reintervention would lead to a delay in the planned curative intent surgery.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8021254
• Report Number: 3005099803-2018-61076
• Device Sequence Number: 1578676
• Product Code: FGE
• UDI-Device Identifier: 08714729758150
• UDI-Public: 08714729758150
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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: 03/18/2017
• Device Model Number: M00570650
• Device Catalogue Number: 7065
• Device Lot Number: 0017805348
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 01/22/2019
• 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: 58 YR
• Patient Weight: 142