EU 4.5X37MM STENT 12 MM DW TIP
Report
- Report Number
- 3008114965-2022-00808
- Event Type
- Malfunction
- Date Received
- December 6, 2022
- Date of Event
- November 21, 2022
- Report Date
- January 18, 2023
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. INITIAL REPORTER PHONE: (B)(6). THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. ONE PICTURE WAS ATTACHED TO THE COMPLAINT FILE IN WHICH IT WAS NOTED THAT THE STENT HAS ONE BENT CONDITION IN ONE OF THE STRUTS. NO OTHER DAMAGES ON THE DEVICE CAN BE APPRECIATED IN THE PICTURE. IT CANNOT BE DETERMINED WHETHER THE STENT IS STILL CONNECTED TO THE DELIVERY WIRE SINCE THE STENT IS BEING HELD BY THE HAND. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED SINCE IT WAS NOTED THAT ONE OF THE STRUTS OF THE STENT WAS KINKED, THE CUSTOMER COMPLAINT REGARDING AN IMPEDED CONDITION WAS NOT ABLE TO BE EVALUATED SINCE A FUNCTIONAL TEST NEEDS TO BE PERFORMED; HOWEVER, THE DAMAGE NOTED IN THE STENT MAY BE THE RESULT OF THE IMPEDED CONDITION FELT DURING THE PROCEDURE. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTO PROVIDED. IF THE PRODUCT IS RECEIVED AFTER THIS INVESTIGATION, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
PRODUCT COMPLAINT # (B)(4). COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION OF AN ANEURYSM TO THE POSTERIOR COMMUNICATING ARTERY, WITH A LARGE TUMOR DIAMETER OF ABOUT 2.5 MM, AN EU 4.5X37MM STENT 12 MM DW TIP (ENC453712, 7161632) BECAME IMPEDED IN Y CONNECTOR AND COULD NOT BE PUSHED INTO THE PROWLER SELECT PLUS MICROCATHETER (PRODUCT/LOT UNKNOWN). THE PHYSICIAN RETRACTED THE STENT AND OBSERVED THAT STENT'S BODY WAS DEFORMED. A NEW STENT OF THE SAME SIZE (4.5MM X 37MM) WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED AND THE SAME MC WAS USED SUCCESSFULLY WITH THE NEW STENT. THERE WAS NO CEREBRAL TARGET LOSS DUE TO THE EVENT. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE TIP OF THE STENT NEAR THE MARKERS WAS KINKED/BENT. THE INTRODUCER WAS FULLY SEATED AND SECURED IN THE HUB. PER THE PHYSICIAN, THE DEVICE WAS NOT TORQUED AT THE TIME. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE RESISTANCE OCCURRED WHEN THE STENT WAS APPROACHING THE MICROCATHETER. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT. ONE PICTURE WAS ATTACHED TO THE COMPLAINT FILE IN WHICH IT WAS NOTED THAT THE STENT HAS ONE BENT CONDITION IN ONE OF THE STRUTS. NO OTHER DAMAGES ON THE DEVICE CAN BE APPRECIATED IN THE PICTURE. IT CANNOT BE DETERMINED WHETHER THE STENT IS STILL CONNECTED TO THE DELIVERY WIRE SINCE THE STENT IS BEING HELD BY THE HAND. A NON-STERILE EU 4.5X37MM STENT 12 MM DW TIP WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, AND IT WAS NOTED THAT THE STENT WAS ALREADY DETACHED FROM THE UNIT. THE DELIVERY WIRE AND THE INTRODUCER WERE RETURNED FOR EVALUATION; BOTH WERE FOUND TO BE IN GOOD CONDITION (I.E., NO KINKS, NO FRACTURES, OR SEPARATIONS). THE STENT COMPONENT WAS INSPECTED UNDER MAGNIFICATION, AND IT WAS FOUND THAT TWO OF THE DISTAL STRUTS WERE BENT. THE OTHER DISTAL END WAS FOUND IN GOOD CONDITION, AND THE MARKER BANDS WERE NOTED TO BE COMPLETELY FLARED. THE CUSTOMER COMPLAINT REGARDING A STENT IMPEDED IN THE MICROCATHETER COULD NOT BE EVALUATED THROUGH FUNCTIONAL TESTING SINCE THE STENT WAS ALREADY DEPLOYED; HOWEVER, THIS CONDITION REASONABLY SUGGESTS THAT THE ENTERPRISE INTRODUCER WAS NOT FULLY SEATED IN THE HUB OF THE MICROCATHETER, AND THIS CAUSED THAT WHEN THE HEALTHCARE PROFESSIONAL TRIED TO ADVANCE THE STENT, THIS PREMATURELY DEPLOYED IN THE Y CONNECTOR, CAUSING THE STENT COMPONENT TO BE UNABLE TO ADVANCE FURTHER. IT IS POSSIBLE THAT THE STENT INADVERTENTLY BECAME DAMAGED DURING THE ADVANCEMENT. BASED ON THIS, THE CUSTOMER COMPLAINT REGARDING, AN IMPEDED CONDITION AND BENT STENT WERE ABLE TO BE CONFIRMED; HOWEVER, THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT RESULTS FROM A DEFECT INHERENTLY RELATED TO THE DEVICE. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF LOT 7161632. THE HISTORICAL RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. IT SHOULD BE NOTED THAT MULTIPLE FACTORS COULD CAUSE PRODUCT FAILURE. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE TO A NEW ONE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION OF AN ANEURYSM TO THE POSTERIOR COMMUNICATING ARTERY, WITH A LARGE TUMOR DIAMETER OF ABOUT 2.5 MM, AN EU 4.5X37MM STENT 12 MM DW TIP (ENC453712, 7161632) BECAME IMPEDED IN Y CONNECTOR AND COULD NOT BE PUSHED INTO THE PROWLER SELECT PLUS MICROCATHETER (PRODUCT/LOT UNKNOWN). THE PHYSICIAN RETRACTED THE STENT AND OBSERVED THAT STENT'S BODY WAS DEFORMED. A NEW STENT OF THE SAME SIZE (4.5MM X 37MM) WAS SWITCHED TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED AND THE SAME MC WAS USED SUCCESSFULLY WITH THE NEW STENT. THERE WAS NO CEREBRAL TARGET LOSS DUE TO THE EVENT. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE TIP OF THE STENT NEAR THE MARKERS WAS KINKED/BENT. THE INTRODUCER WAS FULLY SEATED AND SECURED IN THE HUB. PER THE PHYSICIAN, THE DEVICE WAS NOT TORQUED AT THE TIME. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. THE RESISTANCE OCCURRED WHEN THE STENT WAS APPROACHING THE MICROCATHETER. THERE WERE NO PROCEDURAL DELAYS DUE TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1852431 | EU 4.5X37MM STENT 12 MM DW TIP | INTRACRANIAL NEUROVASCULAR STENT | NJE | MEDOS INTERNATIONAL SARL | 7161632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | PROWLER SELECT PLUS |