EU 4.5X28MM STENT 12 MM DW TIP

Report

Report Number: 3008114965-2022-00265
Event Type: Malfunction
Date Received: April 14, 2022
Date of Event: April 1, 2022
Report Date: September 1, 2022
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

Additional Manufacturer Narrative · 0

MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT PROVIDED / REPORTED. 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. (B)(6) MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 6812655. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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.

Additional Manufacturer Narrative · 0

MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 28MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452812 / 6812655) WAS IMPEDED IN THE TIP OF THE MICROCATHETER AND COULD NOT PASS THROUGH THE TIP. THE PHYSICIAN REMOVED THE STENT FROM THE MICROCATHETER AND THEN THE STENT COMPONENT WAS FOUND ALREADY RELEASED. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. MULTIPLE ATTEMPTS TO OBTAIN PRODUCT FOR ANALYSIS AND OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IF PRODUCT IS RETURNED OR INFORMATION PROVIDED AT A LATER DATE, THE FILE WILL BE UPDATED ACCORDINGLY. 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. THE STENT COMPONENT WAS OBSERVED ALREADY DETACHED FROM THE UNIT. THE INTRODUCER AND THE DELIVERY WIRE WERE ALSO INSPECTED AND WERE BOTH OBSERVED TO BE IN GOOD CONDITION. MICROSCOPIC INSPECTION WAS PERFORMED ON THE STENT COMPONENT. UNDER MAGNIFICATION, NO ABNORMALITIES WERE OBSERVED ON THE STENT COMPONENT (I.E., NO BROKEN STRUTS, NO BROKEN MARKER BANDS, AND NO KINKS). THE MARKER BANDS ON BOTH ENDS WERE CONFIRMED TO BE FLARED. THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT THAT THE STENT COULD NOT PASS THROUGH THE TIP OF THE MICROCATHETER COULD NOT BE TESTED SINCE THE STENT COMPONENT BECAME DETACHED DURING THE PROCEDURE. HOWEVER, IT IS POSSIBLE THAT FORCE MAY HAVE INADVERTENTLY BEEN APPLIED TO EXPOSE THE STENT THROUGH THE MICROCATHETER TIP, OR THAT THERE WAS DIFFICULTY TO REMOVE THE STENT FROM THE MICROCATHETER, RESULTING IN THE STENT DETACHMENT. CLINICAL AND INTRA-PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE REPORTED ISSUE RELATED TO THE PREMATURE DEPLOYMENT OF THE STENT WAS CONFIRMED BASED ON THE APPEARANCE OF THE RETURNED COMPONENT; HOWEVER, NO ABNORMALITIES WERE OBSERVED ON THE RETURNED COMPONENTS THAT COULD HAVE RESULTED IN THE ISSUE ENCOUNTERED DURING THE PROCEDURE. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING, AND PACKAGING OF THE LOT 6812655. THE HISTORY RECORDS INDICATE 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 PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. 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. IF RESISTANCE IS FELT WHILE RECAPTURING THE STENT, DO NOT CONTINUE TO RECAPTURE THE DEVICE. WITHDRAW THE INFUSION CATHETER SLIGHTLY TO UNSHEATHE THE STENT (WITHOUT EXCEEDING THE RECAPTURE LIMIT), AND THEN ATTEMPT TO RECAPTURE THE STENT AGAIN. 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. 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.

Additional Manufacturer Narrative · 0

MANUFACTURER¿S REF. NO: PC-(B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED IN THE PRODUCT ANALYSIS LAB ON 25-AUG-2022. THE RETURNED PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. 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.

Additional Manufacturer Narrative · 0

MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE COMPLAINT PRODUCT IS CURRENTLY NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS. IF THE PRODUCT IS RETURNED OR INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 28MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452812 / 6812655) WAS IMPEDED IN THE TIP OF THE MICROCATHETER AND COULD NOT PASS THROUGH THE TIP. THE PHYSICIAN REMOVED THE STENT FROM THE MICROCATHETER AND THEN THE STENT COMPONENT WAS FOUND ALREADY RELEASED. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT. MULTIPLE ATTEMPTS TO OBTAIN PRODUCT FOR ANALYSIS AND OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IF PRODUCT IS RETURNED OR INFORMATION PROVIDED AT A LATER DATE, THE FILE WILL BE UPDATED ACCORDINGLY. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING, AND PACKAGING OF THE LOT 6812655. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. WITH THE LIMITED INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. THE EXACT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, ANEURYSM SIZE / VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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. 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.

Additional Manufacturer Narrative · 0

MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS MAKE A CORRECTION TO THE SECTION H.2. [CORRECTION]: IN THE 3500A SUPPLEMENTAL #3 REPORT, THE FOLLOW-UP TYPE WAS INCORRECTION DOCUMENTED AS ¿ADDITIONAL INFORMATION.¿ THE CORRECT FOLLOW-UP TYPE IS ¿DEVICE EVALUATION.¿ UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.10, AND H.11. 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. SECTION H.2 ¿IF FOLLOW-UP, WHAT TYPE?¿ WAS INCORRECTLY DOCUMENTED AS ¿ADDITIONAL INFORMATION¿ IN SUPPLEMENTAL #3 REPORT. IT HAS BEEN CORRECTED FROM ¿ADDITIONAL INFORMATION¿ TO ¿DEVICE EVALUATION.¿

Description of Event or Problem · 0

THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 4.5MM X 28MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC452812 / 6812655) WAS IMPEDED IN THE TIP OF THE MICROCATHETER AND COULD NOT PASS THROUGH THE TIP. THE PHYSICIAN REMOVED THE STENT FROM THE MICROCATHETER AND THEN THE STENT COMPONENT WAS FOUND ALREADY RELEASED. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
167007	EU 4.5X28MM STENT 12 MM DW TIP	INTRACRANIAL NEUROVASCULAR STENT	NJE	MEDOS INTERNATIONAL SARL		6812655

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown