Minima Stent System - 8mm FG-0002Recalls & reported problems
Renata Medical, Inc. · Pre-mounted cobalt chromium stent designed for use in the treatment of common congenital and post-operative vascular stenoses. · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00196852805037), received between May 6, 2025 and Sep 16, 2026 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Device Dislodged or Dislocated
On (b)(6) 2026, an 8mm Minima Stent System was implanted by Dr. (b)(6) to treat coarctation of the aorta. The patient then underwent the Glenn procedure with Sano takedown on (b)(6) 2026; this was unrelated to the Minima Stent implant procedure. On (b)(6) 2026, after the (b)(6) 2026 surgery, Dr. (b)(6) performed an echocardiogram and found that the stent had moved approximately 10mm proximal to the lesion. On (b)(6) 2026 another 8mm Minima Stent System was placed during a subsequent transcatheter procedure to relieve the stenosis.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50791061 ↗MalfunctionMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
ONE 8 MM MINIMA STENT WAS USED TO TREAT A NATIVE AORTIC COARCTATION. AFTER THE STENT WAS PLACED, FINAL ANGIOGRAPHY INDICATED THAT THE STENT WAS PLACED IN THE TARGET LOCATION. ROUTINE POST-PROCEDURAL IMAGING IDENTIFIED THAT THE STENT MIGRATED DISTALLY THROUGH THE DESCENDING AORTA BELOW THE DIAPHRAGM. FOUR DAYS AFTER THE IMPLANT PROCEDURE, THE PATIENT UNDERWENT SURGERY TO REPAIR THE COARCTATION. DURING THE REPAIR, THE STENT WAS REMOVED. NO DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21973209 ↗
Other Aortic Stent devices
- Minima Stent System - 6mm FG-0001Renata Medical, Inc. · Aortic Stent1 death10 reports
- CP Stent™ 614311B Braun Interventional Systems, Inc · Aortic stent6 reports
- CP Stent™ 614310B Braun Interventional Systems, Inc · Aortic stent3 reports
- CP Stent™ 614309B Braun Interventional Systems, Inc · Aortic stent3 reports
- CP Stent™ 614308B Braun Interventional Systems, Inc · Aortic stent3 reports
- CP Stent™ 614376B Braun Interventional Systems, Inc · Aortic stent2 reports
- CP Stent™ 614516B Braun Interventional Systems, Inc · Aortic stent2 reports
- CP Stent™ 614375B Braun Interventional Systems, Inc · Aortic stent1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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