EU ENT4.5MMD 28MML WNO DSTL TP
Report
- Report Number
- 3008114965-2023-00185
- Event Type
- Malfunction
- Date Received
- April 6, 2023
- Date of Event
- March 22, 2023
- Report Date
- April 28, 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
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED IN THE PRODUCT ANALYSIS LAB ON 20-APR-2023. THE RETURNED PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00186. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. E.1: THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. H.3: 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. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 7212912. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00186. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATION FINDING OF THE RETURNED DEVICE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 4.5MM X 28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. IT WAS OBSERVED THAT THE STENT COMPONENT WAS NO LONGER ATTACHED TO THE REST OF THE DEVICE AND IT WAS NOT RETURNED FOR EVALUATION. THE DELIVERY WIRE AND THE INTRODUCER WERE FOUND TO BE IN GOOD CONDITION (I.E., NO KINKS, NO FRACTURES, AND NO SEPARATIONS). THE DISTANCE BETWEEN THE DELIVERY WIRE AND THE REFERENCE MARKER AS WELL AS THE RETRACTION BUMP DIAMETER WERE MEASURED AND WERE CONFIRMED TO BE WITHIN SPECIFICATIONS. THE ISSUE DOCUMENTED IN THE COMPLAINT REGARDING THE STENT BEING IMPEDED IN THE MICROCATHETER NOT BE EVALUATED THROUGH FUNCTIONAL TEST AS THE STENT BECAME DETACHED DURING THE PROCEDURE; HOWEVER, THIS CONDITION SUGGESTS THAT THE INTRODUCER OF THE ENTERPRISE WAS NOT FULLY SEATED IN THE MICROCATHETER HUB, CAUSING THE STENT TO EXPAND IN THE HUB OF THE MICROCATHETER. THIS CAUSED THE RESISTANCE AND RESULTED IN THE STENT COMPONENT BEING UNABLE TO ADVANCE FURTHER, WHERE PUSH / PULL FORCE WAS APPLIED SUFFICIENTLY TO DISENGAGE THE STENT FROM THE DELIVERY WIRE. HOWEVER, WITH THE AMOUNT OF INFORMATION AVAILABLE THIS ONLY REMAINS SPECULATIVE. IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THERE IS NO INDICATION THAT THE ISSUES REPORTED IN THE COMPLAINT RESULT FROM A DEFECT INHERENTLY RELATED TO THE ENTERPRISE DEVICE. BASED ON THIS BOTH CUSTOMER COMPLAINTS WERE ABLE TO BE CONFIRMED. THE STENT COMPONENT MIGHT HAVE GOTTEN LOST SOMETIME DURING THE POST-OPERATIVE HANDLING OR DECONTAMINATION OF THE DEVICE. IF ADDITIONAL INFORMATION OR COMPONENTS ARE RECEIVED AT A LATER TIME, THIS INVESTIGATION WILL BE REASSESSED ACCORDINGLY. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 7212912. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT MULTIPLE FACTORS COULD CAUSE PRODUCT FAILURE. THE INSTRUCTIONS FOR USE (IFU) DOES CONTAIN THE FOLLOWING RECOMMENDATION: ¿ THE INTRODUCER MUST BE PROPERLY ENGAGED WITH THE INFUSION CATHETER HUB TO ENABLE STENT INTRODUCTION INTO THE INFUSION CATHETER. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2023-00185 AND 3008114965-2023-00186. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT STENT, A 4.5MM X 28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (ENC452800 / 7212912) WAS IMPEDED IN THE PROXIMAL SECTION OF THE CONCOMITANT MICROCATHETER, A 150CM X 5CM PROWLER SELECT PLUS (606S255X / 30946841) AND COULD NOT ADVANCE FURTHER AFTER SEVERAL ATTEMPTS. THE PHYSICIAN RETRACTED THE STENT AND OBSERVED THAT THE STENT COMPONENT REMAINED IN THE MICROCATHETER AND WAS NO LONGER CONNECTED TO THE DELIVERY WIRE. THE PHYSICIAN REPLACED THE STENT AND THE MICROCATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 31-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE LOCATION OF THE TARGET ANEURYSM WAS THE MIDDLE CEREBRAL ARTERY (MCA). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER DURING THE PROCEDURE. NO OTHER DEVICE WENT THROUGH THE MICROCATHETER. THERE WERE NO VISIBLE KINKS OR OTHER DAMAGES OBSERVED ON THE MICROCATHETER. THE STENT / STENT DELIVERY SYSTEM DID NOT APPEAR DAMAGED. THE REPLACEMENT STENT WAS NOT ANOTHER 4.5MM X 28MM ENTERPRISE VASCULAR RECONSTRUCTION DEVICE. THE REPLACEMENT MICROCATHETER WAS ANOTHER PROWLER SELECT PLUS. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO THE ALLEGED REPORTED PRODUCT ISSUES. THE EVENT DID NOT RESULT IN ANY CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 549145 | EU ENT4.5MMD 28MML WNO DSTL TP | INTRACRANIAL NEUROVASCULAR STENT | NJE | MEDOS INTERNATIONAL SARL | 7212912 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | PROWLER SELECT PLUS 150/5CM |