EU ENT4.5MMD 28MML WNO DSTL TP

Report

Report Number: 3008114965-2021-00678
Event Type: Injury
Date Received: December 15, 2021
Date of Event: September 3, 2021
Report Date: December 15, 2021
Manufacturer: MEDOS INTERNATIONAL SARL
Product Code: NJE
UDI-DI: 10878528008894
PMA / PMN Number: H60001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

MANUFACTURER¿S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: ZHANG K, XIA JC, GAO HL, GAO BL, WANG YF, LI ZS, LI TX, WANG ZL. CASE REPORT: DOUBLE MICRO-GUIDEWIRE TECHNIQUE FOR EMERGENT RESCUE OF PROXIMAL STENT COLLAPSE DURING RECANALIZATION OF NONACUTE OCCLUSION OF VERTEBRAL ARTERY. FRONT NEUROL. 2021 SEP 3;12:671158. DOI: 10.3389/FNEUR.2021.671158. PMID: 34539544; PMCID: PMC8446545. THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE (S) WERE NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (VRD) IS INTENDED FOR USE WITH OCCLUSIVE DEVICES IN THE TREATMENT OF INTRACRANIAL ANEURYSMS. IT IS NOT INTENDED FOR USE AS A STAND-ALONE DEVICE, I.E., WITHOUT SUBSEQUENT COIL EMBOLIZATION OF THE ANEURYSM. THIS STENT WAS USED OFF-LABEL FOR THE TREATMENT OF A V4 SEGMENT OCCLUSION OF THE RIGHT VERTEBRAL ARTERY. 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 ADD THE NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 2.0 × 13 MM GATEWAY BALLOON (STRYKER), 300-CM TRAXCESS MICRO-GUIDEWIRE (0.014 INCH, MEDTRONIC), ECHELON 10 MICROCATHETER (MEDTRONIC) UPDATED SECTIONS: B.4, G.3, G.6, H.2, H.10, AND CONCOMITANT PRODUCTS. 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). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: ZHANG K, XIA JC, GAO HL, GAO BL, WANG YF, LI ZS, LI TX, WANG ZL. CASE REPORT: DOUBLE MICRO-GUIDEWIRE TECHNIQUE FOR EMERGENT RESCUE OF PROXIMAL STENT COLLAPSE DURING RECANALIZATION OF NONACUTE OCCLUSION OF VERTEBRAL ARTERY. FRONT NEUROL. 2021 SEP 3;12:671158. DOI: 10.3389/FNEUR.2021.671158. PMID: 34539544; PMCID: PMC8446545. THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE (S) WERE NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE (VRD) IS INTENDED FOR USE WITH OCCLUSIVE DEVICES IN THE TREATMENT OF INTRACRANIAL ANEURYSMS. IT IS NOT INTENDED FOR USE AS A STAND-ALONE DEVICE, I.E., WITHOUT SUBSEQUENT COIL EMBOLIZATION OF THE ANEURYSM. THIS STENT WAS USED OFF-LABEL FOR THE TREATMENT OF A V4 SEGMENT OCCLUSION OF THE RIGHT VERTEBRAL ARTERY. 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.

Description of Event or Problem · 0

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: ZHANG K, XIA JC, GAO HL, GAO BL, WANG YF, LI ZS, LI TX, WANG ZL. CASE REPORT: DOUBLE MICRO-GUIDEWIRE TECHNIQUE FOR EMERGENT RESCUE OF PROXIMAL STENT COLLAPSE DURING RECANALIZATION OF NONACUTE OCCLUSION OF VERTEBRAL ARTERY. FRONT NEUROL. 2021 SEP 3;12:671158. DOI: 10.3389/FNEUR.2021.671158. PMID: 34539544; PMCID: PMC8446545. OBJECTIVE AND METHODS: THE ARTICLE REPORTS A CASE WITH V4 SEGMENT OCCLUSION OF THE RIGHT VERTEBRAL ARTERY TREATED WITH ENDOVASCULAR STENT ANGIOPLASTY. LOT NUMBER IS NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED EVENT: 4.5MM X 28MM ENTERPRISE STENT. OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 2.0 × 13 MM GATEWAY BALLOON (STRYKER), 300-CM TRAXCESS MICRO-GUIDEWIRE (0.014 INCH, MEDTRONIC), ECHELON 10 MICROCATHETER (MEDTRONIC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: A MALE PATIENT IN HIS 50S UNDERWENT ENDOVASCULAR STENT ANGIOPLASTY OF A V4 SEGMENT OCCLUSION WITH A 4.5MM X 28MM ENTERPRISE STENT. THE ENTERPRISE STENT DEPLOYED AT THE OCCLUSION SEGMENT WAS COLLAPSED AT THE PROXIMAL END AFTER WITHDRAWAL OF THE DELIVERY SYSTEM. IMMEDIATE RESCUING MEASURES WERE TAKEN BY NAVIGATING A MICRO-GUIDEWIRE THROUGH THE LATERAL STENT MESH AT THE PROXIMAL END INTO THE STENT LUMEN FOLLOWED BY ADVANCING A SECOND MICRO-GUIDEWIRE RIGHT THROUGH THE REOPENED PROXIMAL STENT END INTO THE STENT LUMEN FOR DEPLOYMENT OF A SUPPORTING BALLOON-EXPANDABLE APOLLO STENT TO PREVENT STENT COLLAPSE. AFTER STENTING, BOTH STENTS WERE WELL-PATENT WITH FAVORABLE FORWARD FLOW. FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY 6 MONTHS LATER DEMONSTRATED PATENT STENTS AND UNOBSTRUCTED BLOOD FLOW.

Description of Event or Problem · 0

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: ZHANG K, XIA JC, GAO HL, GAO BL, WANG YF, LI ZS, LI TX, WANG ZL. CASE REPORT: DOUBLE MICRO-GUIDEWIRE TECHNIQUE FOR EMERGENT RESCUE OF PROXIMAL STENT COLLAPSE DURING RECANALIZATION OF NONACUTE OCCLUSION OF VERTEBRAL ARTERY. FRONT NEUROL. 2021 SEP 3;12:671158. DOI: 10.3389/FNEUR.2021.671158. PMID: 34539544; PMCID: PMC8446545. OBJECTIVE AND METHODS: THE ARTICLE REPORTS A CASE WITH V4 SEGMENT OCCLUSION OF THE RIGHT VERTEBRAL ARTERY TREATED WITH ENDOVASCULAR STENT ANGIOPLASTY. LOT NUMBER IS NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED EVENT: 4.5MM X 28MM ENTERPRISE STENT. OTHER CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: 2.0 × 13 MM GATEWAY BALLOON (STRYKER), 300-CM TRAXCESS MICRO-GUIDEWIRE (0.014 INCH, MEDTRONIC), ECHELON 10 MICROCATHETER (MEDTRONIC). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: A MALE PATIENT IN HIS 50S UNDERWENT ENDOVASCULAR STENT ANGIOPLASTY OF A V4 SEGMENT OCCLUSION WITH A 4.5MM X 28MM ENTERPRISE STENT. THE ENTERPRISE STENT DEPLOYED AT THE OCCLUSION SEGMENT WAS COLLAPSED AT THE PROXIMAL END AFTER WITHDRAWAL OF THE DELIVERY SYSTEM. IMMEDIATE RESCUING MEASURES WERE TAKEN BY NAVIGATING A MICRO-GUIDEWIRE THROUGH THE LATERAL STENT MESH AT THE PROXIMAL END INTO THE STENT LUMEN FOLLOWED BY ADVANCING A SECOND MICRO-GUIDEWIRE RIGHT THROUGH THE REOPENED PROXIMAL STENT END INTO THE STENT LUMEN FOR DEPLOYMENT OF A SUPPORTING BALLOON-EXPANDABLE APOLLO STENT TO PREVENT STENT COLLAPSE. AFTER STENTING, BOTH STENTS WERE WELL-PATENT WITH FAVORABLE FORWARD FLOW. FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY 6 MONTHS LATER DEMONSTRATED PATENT STENTS AND UNOBSTRUCTED BLOOD FLOW.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1906344	EU ENT4.5MMD 28MML WNO DSTL TP	INTRACRANIAL NEUROVASCULAR STENT	NJE	MEDOS INTERNATIONAL SARL	641CX0202		10878528008894

Patients

Seq	Age	Sex	Outcome	Treatment
1		Male	Required Intervention	2.0 × 13 MM GATEWAY BALLOON (STRYKER)\| 300CM TRAXCESS MICROGUIDEWIRE (MICROVENTION)\| ECHELON 10 MICROCATHETER (MEDTRONIC)