Single Use Biliary Stent V PBD-200-1003Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170185618), received between Aug 14, 2024 and Aug 14, 2024 — classified as 1 death, 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED "COVERED SELF-EXPANDABLE METALLIC STENTS VERSUS PLASTIC STENTS FOR ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY IN PATIENTS WITH MALIGNANT BILIARY OBSTRUCTION." BACKGROUND/AIMS: COVERED SELF-EXPANDABLE METALLIC STENTS (CSEMS) HAVE BECOME POPULAR FOR ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY WITH TRANSMURAL STENTING (EUS-HGS). WE COMPARED THE TIME TO RECURRENT BILIARY OBSTRUCTION (TRBO), COMPLICATIONS, AND REINTERVENTION RATES BETWEEN EUS-HGS USING PLASTIC STENT (PS) AND CSEMS IN PATIENTS WITH UNRESECTABLE MALIGNANCIES AT MULTICENTER INSTITUTIONS IN JAPAN. METHODS: PATIENTS WITH UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION WHO UNDERWENT EUS-HGS BETWEEN APRIL 2015 AND JULY 2020 AT ANY OF THE SIX PARTICIPATING FACILITIES WERE ENROLLED. PRIMARY ENDPOINT: TRBO; SECONDARY ENDPOINTS: RATE OF COMPLICATIONS OTHER THAN RECURRENT BILIARY OBSTRUCTION AND TECHNICAL SUCCESS RATE OF REINTERVENTION WERE EVALUATED. RESULTS: PS AND CSEMS WERE USED FOR EUS-HGS IN 109 AND 43 PATIENTS, RESPECTIVELY. THE TRBO WAS SIGNIFICANTLY LONGER IN THE CSEMS GROUP THAN IN THE PS GROUP (646 VS. 202 DAYS). MULTIVARIATE ANALYSIS IDENTIFIED TWO INDEPENDENT FACTORS ASSOCIA

  Patient problems: Insufficient Information

  MAUDE report 19981463 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED "COVERED SELF-EXPANDABLE METALLIC STENTS VERSUS PLASTIC STENTS FOR ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY IN PATIENTS WITH MALIGNANT BILIARY OBSTRUCTION". BACKGROUND/AIMS: COVERED SELF-EXPANDABLE METALLIC STENTS (CSEMS) HAVE BECOME POPULAR FOR ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY WITH TRANSMURAL STENTING (EUS-HGS). WE COMPARED THE TIME TO RECURRENT BILIARY OBSTRUCTION (TRBO), COMPLICATIONS, AND REINTERVENTION RATES BETWEEN EUS-HGS USING PLASTIC STENT (PS) AND CSEMS IN PATIENTS WITH UNRESECTABLE MALIGNANCIES AT MULTICENTER INSTITUTIONS IN JAPAN. METHODS: PATIENTS WITH UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION WHO UNDERWENT EUS-HGS BETWEEN (B)(6) 2015 AND (B)(6) 2020 AT ANY OF THE SIX PARTICIPATING FACILITIES WERE ENROLLED. PRIMARY ENDPOINT: TRBO; SECONDARY ENDPOINTS: RATE OF COMPLICATIONS OTHER THAN RECURRENT BILIARY OBSTRUCTION AND TECHNICAL SUCCESS RATE OF REINTERVENTION WERE EVALUATED. RESULTS: PS AND CSEMS WERE USED FOR EUS-HGS IN 109 AND 43 PATIENTS, RESPECTIVELY. THE TRBO WAS SIGNIFICANTLY LONGER IN THE CSEMS GROUP THAN IN THE PS GROUP (646 VS. 202 DAYS). MULTIVARIATE ANALYSIS IDENTIFIED TWO INDEPENDENT FACTORS ASSO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Biliary Leak; Chest Pain; Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Peritonitis; Septic Shock; Ulcer; Unspecified Hepatic or Biliary Problem

  MAUDE report 19981388 ↗