Paramount Mini GPS PMB4-5-18-80Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00821684006412), received between Dec 15, 2017 and Feb 9, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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.

• MalfunctionFeb 9, 2018Material Deformation; Material Deformation

  THE PHYSICIAN WAS ATTEMPTING TO USE A PARAMOUNT MINI GPS BALLOON-EXPANDABLE STENT WITH A 6FR NON-MEDTRONIC SHEATH AND A NON-MEDTRONIC GUIDEWIRE TO TREAT A MODERATELY CALCIFIED PLAQUE LESION IN THE PROXIMAL INFERIOR MESENTERIC ARTERY (95%). ARTERY DIAMETER REPORTED AS 4MM AND LESION LENGTH REPORTED AS 20MM. THE VESSEL WAS MODERATELY TORTUOUS. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE VESSEL WAS PRE-DILATED USING A 3X40 NANOCROSS PTA BALLOON. RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE, NO EXCESSIVE FORCE WAS USED AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE DEFORMED STENT WAS REMOVED WITHOUT ANY DIFFICULTY AND A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. NO STENT ELONGATION OR SHORTENING WAS NOTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7262120 ↗
• InjuryDec 15, 2017Fracture; Migration or Expulsion of Device; Fracture; Migration or Expulsion of Device

  ON THE (B)(6) 2014, A PATIENT UNDERWENT TREATMENT FOR LEFT RENAL ARTERY CALCIFIED STENOSIS OF 90% AT THE OSTIUM OF THE VESSEL USING A 5X18 MM PARAMOUNT MINI STENT AND ANGIOPLASTY. THE PROCEDURE USED A 5 FR SHEATH AND A 0.014¿ GUIDEWIRE. THE STENT WAS FIRST DEPLOYED TO 6 AND THEN TO 7 ATM. THE PROCEDURE WAS SUCCESSFUL. DURING A FOLLOW UP FOR THE PROCEDURE ON THE (B)(6) 2017, THE PATIENT WAS EXPERIENCING PAIN IN THE RIGHT LOWER EXTREMITY. AN AORTOGRAM WAS PERFORMED AND IT WAS FOUND A PORTION OF THE PARAMOUNT STENT WAS IN THE MID-DISTAL RIGHT SFA. THE FRACTURED STENT WAS NOT CAUSING VASCULAR COMPROMISE. THE PHYSICIAN OPTED TO PERFORM ANGIOPLASTY OF THE RENAL STENT PORTION TO SECURE IT. REVASCULARIZATION OF THE RIGHT FEMORAL POPLITEAL SEGMENT WAS ALSO PERFORMED WITH ATHERECTOMY PROCEDURE. ON THE (B)(6) 2017, THE LEFT RENAL ARTERY FRACTURED STENT WAS COVERED USING A 4 MM AND 5 MM BALLOON AND THEN DEPLOYING A NON-MEDTRONIC STENT GRAFT TO 12 ATM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7123689 ↗