SMART FLEX
Report
- Report Number
- 3005089785-2023-00132
- Event Type
- Injury
- Date Received
- August 23, 2023
- Date of Event
- July 28, 2023
- Report Date
- September 20, 2023
- Manufacturer
- CORDIS CASHEL
- Product Code
- FGE
- PMA / PMN Number
- K130981
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: B5, G3, H1, H2, H3 AND H6. AS REPORTED, A SMART FLEX 5X100 STENT WAS RELEASES AND DEPLOYED NORMALLY IN THE SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 6 MONTHS LATER, THE PATIENT RETURNED TO THE HOSPITAL FOR AN EXAMINATION AND WAS FOUND TO HAVE AN ABNORMAL DEFORMATION AT THE TIP END OF THE STENT (THE STENT WAS SUSPECTED TO HAVE FRACTURE). THE PATIENT DID NOT HAVE ANY SYMPTOMS. THE STENT WAS NOT POST DILATED AFTER PLACEMENT. THERE WAS NOTHING DONE TO CORRECT THE STENT AFTER THE SIX MONTH FOLLOW UP ANGIO. A STENT WAS NOT PLACED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 250753 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND BASED ON THE INFORMATION PROVIDED, THE REPORTED ¿STENT- FRACTURED¿ COULD NOT BE CONFIRMED AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. ACCORDING TO THE INSTRUCTIONS FOR USE ¿IF RESISTANCE IS ENCOUNTERED AT ANY TIME DURING THE INSERTION PROCEDURE, DO NOT FORCE PASSAGE. RESISTANCE MAY CAUSE DAMAGE TO STENT OR SYSTEM. IF RESISTANCE OCCURS DURING MOVEMENT THROUGH THE SHEATH, CAREFULLY WITHDRAW THE STENT SYSTEM. ONCE STENT DEPLOYMENT HAS BEGUN, THE STENT MUST BE FULLY DEPLOYED. THE SYSTEM IS NOT DESIGNED FOR STENT REPOSITIONING OR RECAPTURING. IF RESISTANCE IS FELT WHEN INITIALLY RETRACTING THE OUTER DEPLOYMENT SHEATH, DO NOT FORCE DEPLOYMENT. CAREFULLY WITHDRAW THE STENT SYSTEM WITHOUT DEPLOYING THE STENT¿. NEITHER THE PHR REVIEW NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN.
A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 250753 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
AS REPORTED, A SMART FLEX 5X100 STENT WAS RELEASES AND DEPLOYED NORMALLY IN THE SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 6 MONTHS LATER, THE PATIENT RETURNED TO THE HOSPITAL FOR AN EXAMINATION AND WAS FOUND TO HAVE AN ABNORMAL DEFORMATION AT THE TIP END OF THE STENT (THE STENT WAS SUSPECTED TO HAVE FRACTURE). THE PATIENT DID NOT HAVE ANY SYMPTOMS. THE STENT WAS NOT POST DILATED AFTER PLACEMENT. THERE WAS NOTHING DONE TO CORRECT THE STENT AFTER THE SIX MONTH FOLLOW UP ANGIO. A STENT WAS NOT PLACED.
AS REPORTED, A SMART FLEX 5X100 STENT WAS RELEASES AND DEPLOYED NORMALLY IN THE SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 6 MONTHS LATER, THE PATIENT RETURNED TO THE HOSPITAL FOR AN EXAMINATION AND WAS FOUND TO HAVE AN ABNORMAL DEFORMATION AT THE TIP END OF THE STENT (THE STENT WAS SUSPECTED TO HAVE FRACTURE). THE PATIENT DID NOT HAVE ANY SYMPTOMS. THE STENT WAS NOT POST DILATED AFTER PLACEMENT. THERE WAS NOTHING DONE TO CORRECT THE STENT AFTER THE SIX MONTH FOLLOW UP ANGIO. A STENT WAS NOT PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1405657 | SMART FLEX | STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS | FGE | CORDIS CASHEL | 250753 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Life Threatening| O | SMARTFLEX (5*100MM). |