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CP Stent™ 614368Recalls & reported problems

B Braun Interventional Systems, Inc · CMCP019 Mounted Covered CP Stent 3.9 18 · 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 04046964899485), received between Dec 6, 2016 and Dec 6, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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

  • Activation Failure1
  • Device Operates Differently Than Expected1
  • Device Slipped1

Patient problems

  • Death1

Recent adverse event reports

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

  • MalfunctionDec 6, 2016Device Slipped; Device Operates Differently Than Expected; Activation Failure

    AS PER THE (B)(6) 2016 REPORT FROM THE DISTRIBUTOR/HOSPITAL - "USED 18MM COVERED MOUNTED STENT FOR A CONDUIT RUPTURE, THE STENT PARTIALLY SLIPPED OFF THE BALLOON. ACCOUNT WAS ABLE TO MANIPULATE IT BACK ON TO THE BALLOON, BUT AS THEY INFLATED THE OUTER BALLOON IT STARTED TO SLIP OFF AGAIN. THE DISTAL 1/3 OF THE STENT DID NOT EXPAND, LEAVING THE RUPTURE UNCOVERED. THEY TRIED TO GET A BALLOON INTO THE DISTAL PORTION OF THE STENT TO EXPAND IT BUT WERE NOT SUCCESSFUL, AS THE PATIENT WAS CODING AND HAD TO BE SENT TO THE OR. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. A 14MM SHEATH WAS USED." ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR/HOSPITAL ON 12/1/2016 - "FROM CONVERSATION BIS SALES REP HAD WITH ACCOUNT: HEMOSTASIS TOOLS WERE USED. STENT STARTED SLIPPING WHEN PHYSICIAN GOT TOWARDS END OF SHEATH, HE NOTICED IT SLIPPED OFF PROXIMALLY, THEN WAS ABLE TO GET BALLOON CENTERED BACK IN STENT. STENT LATER SLIPPED OFF DISTALLY UPON INFLATION OF SECOND BALLOON WHICH CAUSED DISTAL THIRD NOT TO EXPAND. INNER BALLOON WAS INFLATED BEFORE OUTER BALLOON. AT NO TIME WAS STENT PULLED BACK THROUGH HEMOSTASIS VALVE. THEY COULD NOT GET THE 1ST STENT SUPERIOR AND WERE TRYING TO PLACE A 2ND S

    Patient problems: Death

    MAUDE report 6147705 ↗

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