Palmaz BLUE Transhepatic Biliary Stent on SLALOM .018 System PB1860BSSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032036143), received between Mar 1, 2021 and Oct 5, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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.

• InjuryOct 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, TWO 6MM X 18MM PALMAZ STENTS DID NOT COME OFF BALLOON BUT COULD NOT BE WITHDRAWN INTO GUIDE CATHETER. THE STENT CAME OFF BALLOON ONLY WHEN THEY TRIED TO WITHDRAW STENT INTO GUIDE AND SHEATH AND SUBSEQUENTLY CAME OFF INTO SUB CUTANEOUS SPACE. THE PHYSICIAN WAS TRYING TO TREAT THE LEFT RENAL ARTERY FROM THE RIGHT SIDE OF THE PATIENT. THE LESION HAS A 90% STENOSIS AND MEASURED TO BE 12-15MM IN LENGTH. THE VESSEL HAD MILD-MODERATE CALCIFICATION AND TORTUOSITY. THE PALMAZ STENT WOULD NOT CROSS THE HEAVILY CALCIFIED LESION. WHILE TRYING TO REMOVE THE STENT FROM THE PATIENTS BODY, THE STENT WAS STRIPPED OFF THE BALLOON IN THE GROIN WHILE ATTEMPTED TO BE PULLED THROUGH A NON-CORDIS IMA GUIDE CATHETER. ACCORDING TO THE PHYSICIAN, THE STENT WAS NOT IN THE ARTERY. THE STENT WAS LEFT IN THE PATIENTS BODY IN THE SUB CUTANEOUS SPACE. THE SECOND ATTEMPT TO TREAT LEFT RENAL ARTERY WAS MADE FROM THE LEFT SIDE OF THE PATIENT. THE STENT WOULD NOT CROSS THE LESION, SO THE PHYSICIAN ATTEMPTED PRE-DILATE THE LESION WITH A 6MM NON-CORDIS BALLOON. THE BALLOON WAS REMOVED AND THE STENT STILL WOULD NOT CROSS THE LESION. ONCE AGAIN, WHILE PULLING THE STENT THROUGH THE 6F NON-CORDIS IMA GUIDE CAT

  Patient problems: Foreign Body In Patient

  MAUDE report 12578849 ↗
• MalfunctionMar 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED, THE STENT OF A 15MM X 5MM X 80CM PALMAZ BLUE STENT ON SLALOM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON EXPANDABLE STENT DELIVERY SYSTEM (SDS) CAME OFF THE BALLOON PRIOR TO FULL INFLATION. THE STENT WAS PLACED IN THE RENAL ARTERY WHERE IT NEEDED TO BE. THIS DID NOT `1THE OUTCOME OF THE CASE. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL NO BE RETURNED FOR EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 11393369 ↗