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

Model Number M00523490

Device Problems Break (1069); Migration (4003)

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

Event Date 08/07/2023

Event Type  Injury  

Event Description

It was reported to boston scientific that a flexima plus biliary stent was used and implanted during an endoscopic biliary stent placement procedure in the common bile duct, performed on (b)(6), 2023.Post procedure, on (b)(6), 2023, the patient suddenly collapsed and had experienced symptoms of anemia.A gastroscopy procedure was performed, and it was found that the stent had migrated, and the flap was caught in the papillary area when the stent was separated.On (b)(6), 2023, bleeding was confirmed from the papilla, and an endoscopic retrograde cholangiopancreatography for stent removal procedure was performed to remove the stent.The flexima plus biliary stent was successfully removed, and a new 7fr flexima plus biliary stent was implanted into the patient.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: initial reported address 1 and city: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.

Manufacturer Narrative

Block b5 has been updated based on the additional information received on october 3, 2023, and october 11, 2023.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: initial reported address 1 and city: (b)(6).Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2303 captures the additional stent implanted on the patient.Block h11: correction to the initial mdr in block h6 (impact codes).

Event Description

It was reported to boston scientific that a flexima plus biliary stent was used and implanted during an endoscopic biliary stent placement procedure in the common bile duct, performed on (b)(6) 2023.Post procedure, on (b)(6) 2023, the patient suddenly collapsed and had experienced symptoms of anemia.A gastroscopy procedure was performed, and it was found that the stent had migrated, and the flap was caught in the papillary area when the stent was separated.On (b)(6) 2023, bleeding was confirmed from the papilla, and an endoscopic retrograde cholangiopancreatography for stent removal procedure was performed to remove the stent.The flexima plus biliary stent was successfully removed, and a new 7fr flexima plus biliary stent was implanted into the patient.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on october 3, 2023, and october 11, 2023.Received clarification that the stent was not broken and that the reported term of stent separated indicated stent migration.A gastroscopy confirmed that the stent had migrated inside the duodenum.Additionally, compression with ablation and plastic stent implantation were performed to treat the patient's bleeding.

• Brand Name: FLEXIMA PLUS 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17886358
• MDR Text Key: 325091881
• Report Number: 3005099803-2023-05250
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K965147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

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
• Device Model Number: M00523490
• Device Catalogue Number: 2349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention