COVERA VASCULAR COVERED STENT
Report
- Report Number
- 9681442-2025-00232
- Event Type
- Malfunction
- Date Received
- August 5, 2025
- Date of Event
- June 3, 2025
- Report Date
- August 19, 2025
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
- Product Code
- PFV
- UDI-DI
- 00801741106309
- PMA / PMN Number
- P170042
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H11: 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. HOWEVER, THE LOT HISTORY RECORDS OF THIS LOT WERE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT, AND THE PRODUCT WAS FOUND TO HAVE MET THE SPECIFICATION PRIOR TO SHIPMENT. INVESTIGATION SUMMARY: THE DELIVERY SYSTEM SAMPLE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS, IMAGES AND VIDEOS WERE PROVIDED WHICH LEADS TO INCONCLUSIVE RESULTS. IT WAS REPORTED THAT A 5F INTRODUCER WAS USED, THERE WERE NO TRACKING ISSUES AND THERE WAS NO DAMAGE TO THE DELIVERY SYSTEM. BASED ON AVAILABLE INFORMATION AND THE EVALUATION OF THE RETURNED SAMPLE, THE INVESTIGATION IS CLOSED WITH INCONCLUSIVE RESULTS FOR PARTIAL DEPLOYMENT. A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE ESTABLISHED. LABELING REVIEW: IN REVIEWING THE RELEVANT LABELING FOR THIS PRODUCT, THE POTENTIAL ISSUE WAS FOUND ADDRESSED. BASED ON THE IFU SUPPLIED WITH THIS PRODUCT DELIVERY SYSTEM SPECIFIC EVENTS THAT COULD BE ASSOCIATED WITH CLINICAL COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO FAILURE TO DEPLOY AND HIGH DEPLOYMENT FORCES. REGARDING CORRECT DEPLOYMENT THE IFU STATES: MAINTAIN A STATIONARY HOLD ON THE WHITE STABILITY SHEATH DURING COVERED STENT DEPLOYMENT, HOLD THE WHITE STABILITY SHEATH AS CLOSE AS POSSIBLE TO THE INTRODUCER WITHOUT TOUCHING THE DARK BROWN MOVING CATHETER OF THE DISTAL CATHETER ASSEMBLY. MAINTAIN THE REMAINDER OF THE WHITE STABILITY SHEATH, RELAXED AND AVOID TENSION. BASED ON THE IFU MATERIAL REQUIRED ARE 0.035 INCH GUIDEWIRE OF APPROPRIATE LENGTH, INTRODUCER SHEATH WITH APPROPRIATE INNER DIAMETER. THE LABELING PICTOGRAMS INDICATE THE USE OF AN 8F INTRODUCER. REGARDING PREPARATION THE IFU STATES: PRE-DILATE THE STENOSIS WITH A PTA BALLOON CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE LESION TO BE TREATED. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE 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: MANUFACTURING REVIEW: A MANUFACTURING ROOT CAUSE WAS CONSIDERED; HOWEVER, THE LOT HISTORY REVIEW OF THIS PRODUCT WAS PERFORMED, AND THE PRODUCT WAS FOUND TO HAVE MET THE SPECIFICATION PRIOR TO SHIPMENT. BASED ON THE INFORMATION AVAILABLE A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. INVESTIGATION SUMMARY: THE DELIVERY SYSTEM SAMPLE WAS RETURNED FOR EVALUATION, AND THE COVERED STENT WAS PARTIALLY DEPLOYED; DURING TESTING, FURTHER DEPLOYMENT FAILED WHICH LEADS TO CONFIRMED RESULTS FOR PARTIAL DEPLOYMENT. THERE WAS NO INDICATION OF MANUFACTURING DEFICIENCIES. THEREFORE, THE RESULT OF THE INVESTIGATION, IT WAS REPORTED THAT A 5F INTRODUCER WAS USED, THERE WERE NO TRACKING ISSUES AND THERE WAS NO DAMAGE TO THE DELIVERY SYSTEM. BASED ON AVAILABLE INFORMATION AND THE EVALUATION OF THE RETURNED SAMPLE, THE INVESTIGATION IS CLOSED WITH CONFIRMED RESULTS FOR PARTIAL DEPLOYMENT. A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE ESTABLISHED. LABELLING REVIEW: IN REVIEWING THE RELEVANT LABELING FOR THIS PRODUCT, THE POTENTIAL ISSUE WAS FOUND ADDRESSED. BASED ON THE IFU SUPPLIED WITH THIS PRODUCT DELIVERY SYSTEM SPECIFIC EVENTS THAT COULD BE ASSOCIATED WITH CLINICAL COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO FAILURE TO DEPLOY AND HIGH DEPLOYMENT FORCES. REGARDING CORRECT DEPLOYMENT THE IFU STATES: MAINTAIN A STATIONARY HOLD ON THE WHITE STABILITY SHEATH DURING COVERED STENT DEPLOYMENT (¿). HOLD THE WHITE STABILITY SHEATH AS CLOSE AS POSSIBLE TO THE INTRODUCER WITHOUT TOUCHING THE DARK BROWN MOVING CATHETER OF THE DISTAL CATHETER ASSEMBLY. MAINTAIN THE REMAINDER OF THE WHITE STABILITY SHEATH (...) RELAXED AND AVOID TENSION." BASED ON THE IFU MATERIAL REQUIRED ARE (...) 0.035-INCH GUIDEWIRE OF APPROPRIATE LENGTH (...), INTRODUCER SHEATH WITH APPROPRIATE INNER DIAMETER". THE LABELING PICTOGRAMS INDICATE THE USE OF AN 8F INTRODUCER. REGARDING PREPARATION THE IFU STATES: PRE-DILATE THE STENOSIS WITH A PTA BALLOON CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE LESION TO BE TREATED. G3, H6 (METHOD, RESULT). SECTION A THROUGH F ¿ THE INFORMATION PROVIDE 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.
ON (B)(6) 2025, A PATIENT UNDERWENT STENT GRAFT PLACEMENT PROCEDURE USING THE COVERA VASCULAR COVERED STENT IN THE RIGHT MEDIAN CUBITAL VEIN VIA FISTULA. DURING THE PROCEDURE, THE STENT PLACED IN THE VESSEL ALLEGEDLY DEPLOYED PARTIALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
ON (B)(6) 2025, A PATIENT UNDERWENT STENT GRAFT PLACEMENT PROCEDURE USING THE COVERA VASCULAR COVERED STENT IN THE RIGHT MEDIAN CUBITAL VEIN VIA FISTULA. SURING THE PROCEDURE, THE STENT PLACED IN THE VESSEL ALLEGEDLY DEPLOYED PARTIALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2634006 | COVERA VASCULAR COVERED STENT | VASCULAR COVERED STENT | PFV | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG | ANJW2388 | 00801741106309 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |