E-LUMINEXX VASCULAR STENTS
Report
- Report Number
- 9681442-2017-00273
- Event Type
- Injury
- Date Received
- September 28, 2017
- Date of Event
- September 1, 2017
- Report Date
- November 27, 2017
- Manufacturer
- ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
- Product Code
- NIO
- PMA / PMN Number
- P080007
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
NO HOSPITAL/MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION TO DATE. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE CATALOG NUMBER IDENTIFIED HAS NOT BEEN CLEARED IN THE US, BUT IS SIMILAR TO THE BARD E-LUMINEXX VASCULAR STENTS PRODUCTS THAT ARE CLEARED IN THE US. THE 510 K NUMBER AND PRO CODE FOR THE BARD E-LUMINEXX VASCULAR STENTS PRODUCTS. ACCORDINGLY, THIS EVENT HAS BEEN DETERMINED TO BE MDR REPORTABLE. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF 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 BARD.
THE LOT HISTORY RECORDS 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. NO RELEVANT MANUFACTURING PROCESS CHANGES HAVE BEEN IMPLEMENTED, THAT COULD HAVE LED TO THE EVENT REPORTED. NO ADDITIONAL COMPLAINT HAS BEEN PREVIOUSLY REPORTED FOR THIS LOT NUMBER. BASED ON THE COMPLETED INVESTIGATION AND AVAILABLE INFORMATION, THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. IN REVIEWING THE APPLICABLE LABELING, POTENTIAL ISSUES WERE FOUND ADDRESSED. IN REGARDS TO CORRECT HOLDING DURING DEPLOYMENT THE APPLICABLE IFU STATES: "DURING STENT DEPLOYMENT, THE ENTIRE LENGTH OF THE CATHETER SYSTEM SHOULD BE KEPT AS STRAIGHT AS POSSIBLE. MAINTAINING A STRAIGHT CATHETER UNDER SLIGHT TENSION DURING STENT DEPLOYMENT IS RECOMMENDED TO IMPROVE PLACEMENT ACCURACY."; "DO HOLD THE DELIVERY SYSTEM CATHETER DURING STENT DEPLOYMENT."; "AS WITH ALL SELF-EXPANDING NITINOL STENTS, CAREFUL ATTENTION DURING STENT DEPLOYMENT IS WARRANTED TO MITIGATE THE POTENTIAL FOR MOVEMENT OF THE STENT."' REGARDING DIFFICULT DEPLOYMENT, THE IFU STATES: "SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING THE PROCEDURE, THE ENTIRE SYSTEM (INTRODUCER SHEATH OR GUIDING CATHETER AND STENT DELIVERY SYSTEM) SHOULD BE REMOVED AS A SINGLE UNIT."
MANUFACTURING REVIEW: A MANUFACTURING REVIEW COULD NOT BE PERFORM AS THE LOT NUMBER WAS UNKNOWN. INVESTIGATION SUMMARY: THE CATHETER SAMPLE HAS NOT BEEN RETURNED AND IMAGES HAVE NOT BEEN PROVIDED. THEREFORE, THE EVALUATION OF THE ALLEGED ISSUE WAS NOT POSSIBLE AND THE INVESTIGATION WILL BE CLOSED WITH INCONCLUSIVE RESULT. BASED ON THE INFORMATION AVAILABLE AND BECAUSE THE SAMPLE/IMAGES HAVE NOT BEEN PROVIDED FOR EVALUATION A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. LABELING REVIEW: IN REVIEWING THE APPLICABLE LABELING, POTENTIAL ISSUES WERE FOUND ADDRESSED. IN REGARDS TO CORRECT HOLDING DURING DEPLOYMENT THE APPLICABLE IFU STATES: 'DURING STENT DEPLOYMENT, THE ENTIRE LENGTH OF THE CATHETER SYSTEM SHOULD BE KEPT AS STRAIGHT AS POSSIBLE. MAINTAINING A STRAIGHT CATHETER UNDER SLIGHT TENSION DURING STENT DEPLOYMENT IS RECOMMENDED TO IMPROVE PLACEMENT ACCURACY.', 'DO NOT HOLD THE DELIVERY SYSTEM CATHETER DURING STENT DEPLOYMENT.', 'AS WITH ALL SELF-EXPANDING NITINOL STENTS, CAREFUL ATTENTION DURING STENT DEPLOYMENT IS WARRANTED TO MITIGATE THE POTENTIAL FOR MOVEMENT OF THE STENT.', AND 'TO MAXIMIZE STENT PLACEMENT ACCURACY, SLOWLY AND DELIBERATELY DEPLOY THE DISTAL PORTION OF THE STENT UNTIL YOU HAVE VISUAL CONFIRMATION OF WALL APPOSITION BEFORE STEADILY DEPLOYING THE REMAINING LENGTH OF THE STENT.' IN REGARDS TO STENT SIZE SELECTION THE IFU STATES: 'FOR TARGET LUMENS RANGING FROM 3 MM TO 9 MM, SELECT A STENT WITH AN UNCONSTRAINED DIAMETER OF 1 MM LARGER THAN THE TARGET LUMEN. FOR TARGET LUMENS RANGING FROM 9 MM TO 13 MM, SELECT A STENT WITH AN UNCONSTRAINED DIAMETER OF 1 TO 2 MM LARGER THAN THE TARGET LUMEN.' IN REGARDS TO DIFFICULT DEPLOYMENT, THE IFU STATES: 'SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME DURING THE PROCEDURE, THE ENTIRE SYSTEM (INTRODUCER SHEATH OR GUIDING CATHETER AND STENT DELIVERY SYSTEM) SHOULD BE REMOVED AS A SINGLE UNIT.' (B)(4).
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT JUMPED DUE TO THE RESISTANCE THAT WAS MET DURING DEPLOYMENT. AFTER MULTIPLE ATTEMPTS, THE STENT WAS DEPLOYED, HOWEVER PLACEMENT OF STENT WAS NOT OPTIMAL. THROMBUS WAS FORMED AFTER STENT DEPLOYMENT. CURRENT PATIENT STATUS IS UNKNOWN.
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE INTENDED FOR THE ILIAC ARTERY WITH ACCESS THROUGH THE FEMORAL ARTERY AND MILD CALCIFICATION IN THE TRACKING VESSEL, THE STENT JUMPED DUE TO THE RESISTANCE THAT WAS MET DURING DEPLOYMENT. AFTER MULTIPLE ATTEMPTS, THE STENT WAS DEPLOYED, HOWEVER PLACEMENT OF STENT WAS NOT OPTIMAL. THROMBUS WAS FORMED AFTER STENT DEPLOYMENT. AN ADDITIONAL DEVICE WAS USED TO COVER THE LESION AND COMPLETE THE PROCEDURE. CURRENT PATIENT STATUS IS UNKNOWN.
IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT JUMPED DUE TO THE RESISTANCE THAT WAS MET DURING DEPLOYMENT. AFTER MULTIPLE ATTEMPTS, THE STENT WAS DEPLOYED, HOWEVER PLACEMENT OF STENT WAS NOT OPTIMAL. THROMBUS WAS FORMED AFTER STENT DEPLOYMENT. CURRENT PATIENT STATUS IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 680200 | E-LUMINEXX VASCULAR STENTS | VASCULAR STENT | NIO | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG | ANZJ1482 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |