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CP Stent™ 614497Recalls & reported problems

B Braun Interventional Systems, Inc · CMCP042 Mounted Covered CP Stent 3.9 30 · Class 3 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046955091706), received between Apr 25, 2019 and Apr 25, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Physical Resistance/Sticking1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 25, 2019Detachment of Device or Device Component; Physical Resistance/Sticking

    AS REPORTED TO NUMED ON A REPORT FROM THE DISTRIBUTOR: "INADEQUATE COVER FIXATION TO STENT. THE CP STENT COVER GOT STUCK IN A COOK CHECKFLO 18FR INTRODUCER SHEATH WHILE ADVANCING THE STENT THROUGH THE SHEATH. THE PHYSICIAN SAW THE STENT VIA FLUOROSCOPY AND FELT RESISTANCE. THEY RETRACTED BACK THROUGH THE HEMOSTASIS VALVE AND THE COVER CAME OUT SEPARATELY FROM THE STENT. UMBILICAL TAPE WAS USED TO TRY TO RE-CRIMP THE STENT, HOWEVER IT DID NOT WORK. THE STENT WAS ADVANCED UNCOVERED INTO THE VALVE SUCCESSFULLY. THE INDICATION THE PHYSICIAN WAS USING THE PRODUCT FOR: RVOT AND TRANSCATHETER VALVE IMPLANT. CRIMPING WAS INVOLVED ONLY AFTER THE COVER CAME OFF OF THE STENT AFTER INITIAL ADVANCEMENT INTO INTRODUCER. THE RING MANDRIL WAS NOT USED DURING THE CRIMPING PROCESS. THE STENT DID NOT SLIP. NEITHER SALINE NOR CONTRAST MEDIA WAS USED DURING PREP. THE INNER BALLOON WAS INFLATED BEFORE THE OUTER BALLOON. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE PATIENT CONDITION POST PROCEDURE WAS GOOD, THE CASE WAS SUCCESSFUL". "IT IS UNCLEAR IF THE HEMOSTASIS TOOLS WERE USED".

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8549187 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.