SMART CONTROL NITINOL STENT SYSTEM
Report
- Report Number
- 9616099-2012-00765
- Event Type
- Injury
- Date Received
- December 26, 2012
- Date of Event
- November 28, 2012
- Report Date
- December 5, 2012
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIO
- PMA / PMN Number
- P020036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2012-00765 AND 9616099-2012-00766.
THE COMPLAINT RECEIVED STATES THAT DURING A PTA PROCEDURE, THE SMART CONTROL DEVICE HAD PREMATURE DEPLOYMENT. AS REPORTED BY AN AFFILIATE, DURING A PROCEDURE USING A CONTRALATERAL APPROACH, THE LESION WAS INITIALLY PRE-DILATION WITH AN AVIATOR PLUS BALLOON CATHETER. A SMART CONTROL (LOT #15615205) WAS DELIVERED TO THE LESION, BUT THE STENT WAS TRAPPED AT THE LESION. IT WAS NOTED THAT IT WAS NOT A FAILURE TO CROSS. THEN, THE OUTER SHEATH WAS WITHDRAWN AND ALTHOUGH THE LOCKING PIN HAD BEEN IN PLACE THE STENT GRADUALLY STARTED TO BE RELEASED AND THE STENT WAS DEPLOYED AND IMPLANTED IN THE DISTAL PORTION OF THE LESION. IT IS UNKNOWN IF THE STENT WAS IMPLANTED DELIBERATELY WITH THE INTENTION OF PLACING ADDITIONAL STENTS PROXIMALLY. AN ADDITIONAL SMART CONTROL (LOT #15570023) WAS DELIVERED TO THE LESION IN THE ATTEMPT TO BE PLACED PROXIMALLY AND NEXT TO THE FIRST STENT. HOWEVER, THE OUTER SHEATH OF THE SMART CONTROL WAS WITHDRAWN AND THE DISTAL PORTION (2MM) OF STENT GRADUALLY STARTED TO BE RELEASED ALTHOUGH THE LOCKING PIN HAD BEEN AT THE PLACE. THEN, THE SMART CONTROL WAS REMOVED FROM THE PATIENT WITHOUT STENT PLACEMENT AND WITH NO DIFFICULTIES. CONSEQUENTLY, TWO ADDITIONAL SMART CONTROL STENTS (LOT #S C06080M AND C06060M WERE PLACED PROXIMALLY NEXT TO THE FIRST INITIAL STENT WITHOUT ANY ISSUES. THE PROCEDURE WAS FINISHED SUCCESSFULLY. IT WAS REPORTED THAT THE OUTER SHEATH WAS WITHDRAWN WITHOUT INTENTION, AND THE STENT WAS NOT PLACED AT WRONG SPOT. IT WAS NOTED THAT THREE SMART CONTROL STENTS (LOT #S) 15615205, C06080M, C06060M WERE PLACED AT THE LESION. THE SMART CONTROL WITH LOT NUMBER 15570023 WAS NOT IMPLANTED. THE RIGHT SFA WAS INVOLVED IN THE PROCEDURE AND DESCRIBED AS BEING HEAVILY CALCIFIED. IT IS UNKNOWN IF THE LESION WAS DE NOVO OR TORTUOUS. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. (B)(4). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15570023 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ONE NON-STERILE SMART CONTROL, ILIAC 6X100ML WAS RECEIVED COILED INSIDE A PLASTIC BAG. STENT WAS PARTIALLY DEPLOYED (8MM). LOCKING PIN WAS RECEIVED IN PLACE. NO OTHER DISCREPANCIES WERE FOUND. THE OUTER LENGTH WAS MEASURED AND FOUND WITHIN SPECIFICATION. DEPLOYMENT PROCESS COULD NOT BE PERFORMANCE WITH LOCKING PIN IN PLACE. HOWEVER WITHOUT LOCKING PIN WAS PERFORMED SUCCESSFULLY ACCORDING TO PROCEDURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE FAILURE "SDS - DEPLOYMENT DIFFICULTY-PREMATURE/IN PATIENT" REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THIS CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. CONTROLS ARE IN PLACED AT THE FINAL ASSEMBLY AND PACKAGING PROCESS TO DETECT THESE KIND OF ISSUE "(B)(4) 100% FINAL INSPECTION." NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE FAILURE IS MANUFACTURING PROCESS. THEREFORE NO ACTIONS WERE TAKEN. THE FAILURE "SDS - DEPLOYMENT DIFFICULTY-PREMATURE/IN PATIENT" REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THIS CONDITION COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.
AS REPORTED BY AN AFFILIATE, DURING A PROCEDURE USING A CONTRALATERAL APPROACH, THE LESION WAS INITIALLY PRE-DILATION WITH A AVIATOR PLUS BALLOON CATHETER. A SMART CONTROL (LOT#15615205) WAS DELIVERED TO THE LESION, BUT THE STENT WAS TRAPPED AT THE LESION. THEN, THE OUTER SHEATH WAS WITHDRAWN AND ALTHOUGH THE LOCKING PIN HAD BEEN IN PLACE THE STENT GRADUALLY STARTED TO BE RELEASED AND THE STENT WAS DEPLOYED AND IMPLANTED IN THE DISTAL PORTION OF THE LESION. THEN, ANOTHER SMART CONTROL (LOT#15570023) WAS DELIVERED TO THE LESION IN THE ATTEMPT TO BE PLACED PROXIMALLY AND NEXT TO THE FIRST STENT. HOWEVER, THE OUTER SHEATH OF THE SMART CONTROL WAS WITHDRAWN AND THE DISTAL PORTION (2MM) OF STENT GRADUALLY STARTED TO BE RELEASED ALTHOUGH THE LOCKING PIN HAD BEEN AT THE PLACE. THEN, THE SMART CONTROL WAS REMOVED FROM THE PATIENT WITHOUT STENT PLACEMENT. CONSEQUENTLY, TWO ADDITIONAL SMART CONTROL STENTS (LOT#S C06080M AND C06060M WERE PLACED PROXIMALLY NEXT TO THE FIRST INITIAL STENT WITHOUT ANY ISSUES. THE PROCEDURE WAS FINISHED SUCCESSFULLY. IT WAS NOTED THAT THREE SMART CONTROL STENTS (LOT #'S) 15615205, C06080M, C06060M WERE PLACED AT THE LESION. THE SMART CONTROL WITH LOT NUMBER 15570023 WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMART CONTROL NITINOL STENT SYSTEM | SELF EXPANDING STENTS (NIO) | NIO | CORDIS DE MEXICO | NA | 15570023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |