EU 4.5X37MM STENT 12 MM DW TIP

Report

Report Number: 3008114965-2022-00792
Event Type: Malfunction
Date Received: December 14, 2022
Date of Event: November 28, 2022
Report Date: December 14, 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. THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT STENT, A 4.5MM X 37MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD)( ENC453712 / 6920548) WAS IMPEDED IN THE MIDDLE PART OF THE CONCOMITANT MICROCATHETER AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN RETRACTED THE STENT AND THE MICROCATHETER AND REPLACED BOTH DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. PER THE CERENOVUS SALES REPRESENTATIVE, THE 4.5MM X 37MMENTERPRISE® VRD WAS IMPEDED IN THE MIDDLE PART OF A COMPETITOR BRAND MICROCATHETER AND COULD NO LONGER BE ADVANCED. THE PHYSICIAN RETRACTED THE STENT, THE GUIDE CATHETER, A 6F, 100CM ENVOY® GUIDING CATHETER (67025800 / 30824156), THE MICROCATHETER AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE ADDITIONAL INFORMATION CONFIRMED THERE WAS NO REPORT OF ANY PATIENT INJURY. ON (B)(6) 2022, THE CERENOVUS SALES REPRESENTATIVE CONFIRMED THAT THE COMPLAINT PRODUCT WAS A 4.5MM X 37MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD)( ENC453712 / 6920548). ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. PER THE CERENOVUS SALES REPRESENTATIVE, THE COMPLAINT PRODUCT WAS DISCARDED AND IS NO LONGER AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 6920548. THE HISTORY RECORD INDICATES 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 INFORMATION AVAILABLE AND WITHOUT THE COMPLAINT PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS, THE REPORTED ISSUE IN THE COMPLAINT CANNOT BE CONFIRMED. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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 MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. 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 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. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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.

Description of Event or Problem · 0

THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT STENT, A 4.5MM X 37MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD)( ENC453712 / 6920548) WAS IMPEDED IN THE MIDDLE PART OF THE CONCOMITANT MICROCATHETER AND COULD NOT BE FURTHER ADVANCED. THE PHYSICIAN RETRACTED THE STENT AND THE MICROCATHETER AND REPLACED BOTH DEVICES TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. PER THE CERENOVUS SALES REPRESENTATIVE, THE 4.5MM X 37MMENTERPRISE® VRD WAS IMPEDED IN THE MIDDLE PART OF A COMPETITOR BRAND MICROCATHETER AND COULD NO LONGER BE ADVANCED. THE PHYSICIAN RETRACTED THE STENT, THE GUIDE CATHETER, A 6F, 100CM ENVOY® GUIDING CATHETER (67025800 / 30824156), THE MICROCATHETER AND SWITCHED TO NEW DEVICES TO COMPLETE THE PROCEDURE. THE ADDITIONAL INFORMATION CONFIRMED THERE WAS NO REPORT OF ANY PATIENT INJURY. ON (B)(6) 2022, THE CERENOVUS SALES REPRESENTATIVE CONFIRMED THAT THE COMPLAINT PRODUCT WAS A 4.5MM X 37MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD)( ENC453712 / 6920548). ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. PER THE CERENOVUS SALES REPRESENTATIVE, THE COMPLAINT PRODUCT WAS DISCARDED AND IS NO LONGER AVAILABLE TO BE RETURNED FOR EVALUATION AND ANALYSIS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
475888	EU 4.5X37MM STENT 12 MM DW TIP	INTRACRANIAL NEUROVASCULAR STENT	NJE	MEDOS INTERNATIONAL SARL		6920548

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown		ENVOY 6F, MPD 100CM