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

Device Problem Migration (4003)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the year the literature was published.The upn and lot number of the suspect device was not provided in the literature; therefore, the manufacture and expiration dates are unknown.Literature source: fuccio, l., sansone, v., mosconi, c., golfieri, r., & bazzoli, f.(2019).Hemostatic powder for the intraductal treatment of biliary cancer bleeding.Videogie, 4(12), 565-566.Https://doi.Org/10.1016/j.Vgie.2019.08.008.(b)(4).The stent remains implanted; 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 Description

Boston scientific became aware of an event involving two wallstent uncovered stents through the article " hemostatic powder for the intraductal treatment of biliary cancer bleeding" by dr.Lorenzo fuccio, et al.According to the literature, two uncovered wallstents were implanted to treat cholangiocarcinoma during a stent implantation procedure.The patient was deemed not suitable for curative resection because of her comorbidities and age.Twelve days post stent placement, the patient became hemodynamically unstable with a sudden drop of hemoglobin level to 5.8 g/dl and melena was noted.Endoscopic examination showed active arterial oozing and a large blood clot, almost completely covering the two stents.Partial distal dislodgement of the uncovered stents was noted and the physician decided to use hemostatic powder to treat the bleeding.During the procedure, a hemospray cannula was inserted inside the left stent, up to the hilum, and the powder was sprayed while withdrawing the cannula down to the papilla.Active bleeding stopped thereafter, and the patient remained asymptomatic after the procedure.Follow-up examinations showed a rise of hemoglobin level, whereas the bilirubin value remained just above normal (1.41 mg/dl).Because no curative options could be offered to the patient, she was discharged 16 days later.

• Brand Name: WALLSTENT BILIARY
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12108680
• MDR Text Key: 259662772
• Report Number: 3005099803-2021-03220
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2021

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: 06/12/2021
• Initial Date FDA Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR