COVERA PLUS VASCULAR COVERED STENT
Report
- Report Number
- 9681442-2025-00208
- Event Type
- Injury
- Date Received
- July 9, 2025
- Date of Event
- April 22, 2025
- Report Date
- September 16, 2025
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
- Product Code
- PFV
- PMA / PMN Number
- P170042
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE COVERA PLUS VASCULAR COVERED STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE COVERA PLUS VASCULAR COVERED STENT SYSTEM PRODUCTS ARE IDENTIFIED IN D2 AND G4. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
H11: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE COVERA PLUS VASCULAR COVERED STENT SYSTEM PRODUCTS THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE COVERA PLUS VASCULAR COVERED STENT SYSTEM PRODUCTS ARE IDENTIFIED IN D2 AND G4. MANUFACTURING REVIEW: BASED ON THE INFORMATION AVAILABLE IT IS NOT REASONABLY SUGGESTED THAT A MANUFACTURING PROCESS MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. INVESTIGATION SUMMARY: THE PHYSICAL SAMPLE WAS NOT RETURNED FOR EVALUATION. THE STENT REMAINS IMPLANTED. NO X-RAY IMAGES WERE PROVIDED FOR EVALUATION. BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION IS CLOSED WITH INCONCLUSIVE RESULT. A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. LABELING REVIEW: THE RELEVANT LABELING FOR THIS PRODUCT WAS REVIEWED. IT WAS FOUND THAT THE INSTRUCTIONS FOR USE (IFU) SUFFICIENTLY ADDRESS THE POTENTIAL RISK. BASED ON THE IFU COMPLICATIONS AND ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE COVERA PLUS COVERED STENT MAY INCLUDE THE USUAL COMPLICATIONS ASSOCIATED WITH ENDOVASCULAR STENT AND COVERED STENT PLACEMENT AND DIALYSIS SHUNT REVISIONS, WHICH INCLUDES OBSTRUCTION OF FLOW, INJURY, AND RESTENOSIS OF THE TARGET VESSEL. E1, G2, G3, H6 (METHOD). SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
IT WAS REPORTED THAT POST AFTER PLACEMENT OF A COVERED STENT IN THE RIGHT COMMON ILIAC ARTERY, THE DEVICE ALLEGEDLY HAD IN-STENT STENOSIS. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.
IT WAS REPORTED THAT POST AFTER PLACEMENT OF A COVERED STENT IN THE RIGHT COMMON ILIAC ARTERY, THE DEVICE ALLEGEDLY HAD IN-STENT STENOSIS. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148454 | COVERA PLUS VASCULAR COVERED STENT | VASCULAR COVERED STENT | PFV | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG | ANEN1927 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |