ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

Report

Report Number: 1058196-2013-00173
Event Type: Injury
Date Received: June 21, 2013
Date of Event: January 1, 2013
Report Date: January 1, 2013
Manufacturer: CORDIS NEUROVASCULAR, INC.
Product Code: NJE
PMA / PMN Number: H60001
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

THE REPORT OF ASYMPTOMATIC IN-STENT OCCLUSION OF AN ENTERPRISE VRD (ENC452812/01418934) APPROXIMATELY 6 MONTHS POST IMPLANTATION WAS NOTED IN THE ARTICLE BY K. KONO ET AL, ¿DELAYED IN-STENT OCCLUSION DUE TO STENT-RELATED CHANGES IN VASCULAR GEOMETRY AFTER CEREBRAL ANEURYSM TREATMENT¿, NEUROL MED CHIR (TOKYO) 53, 182-185, 2013. ACCORDING TO THE PHYSICIAN, THE EVENT WAS RELATED TO THE VRD AS WELL AS ALTERNATION IN BLOOD FLOW. THE PHYSICIAN ALSO COMMENTED THAT THE BLOOD FLOW BETWEEN POSTERIOR INFERIOR CEREBELLAR ARTERY AND ANTERIOR SPINAL ARTERY WAS OBSTRUCTED DUE TO VRD OCCLUSION; IT AFFECTED BLOOD SUPPLY TO LEFT ANTERIOR SPINAL ARTERY. THE PATIENT REMAINED NEUROLOGICALLY INTACT 16 MONTHS AFTER THE INTERVENTION. AT BASELINE, THE (B)(6) MALE WAS REFERRED WITH AN INCIDENTALLY DISCOVERED UNRUPTURED ANEURYSM WITH A MAXIMUM SIZE OF 8.6 MM ON THE LEFT VERTEBRAL ARTERY (VA). THE ANEURYSM WAS LOCATED PROXIMAL TO THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA). ONE WEEK BEFORE THE INTERVENTION, THE PATIENT WAS TREATED WITH ONGOING 75 MG CLOPIDOGREL AND 100 MG ASPIRIN PER DAY. STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH A 28MM ENTERPRISE STENT. THE STENT WAS DEPLOYED TO COVER THE NECK OF THE ANEURYSM SO THAT THE DISTAL END OF THE STENT WAS LOCATED BETWEEN THE ANTERIOR SPINAL ARTERY (ASA) AND PICA. THE INTERVENTION WAS SUCCESSFULLY PERFORMED AND NO COMPLICATIONS OCCURRED. AT SIX MONTH FOLLOW-UP THE ANGIOGRAM SHOWED ASYMPTOMATIC IN-STENT OCCLUSION OF THE TREATED VESSEL. THE LEFT VA WAS OCCLUDED FROM THE BRANCH OF THE LEFT PICA. THE DUAL ANTIPLATELET MEDICATIONS WERE CONTINUED AFTER INITIAL TREATMENT; THEREFORE IT WAS REPORTED THAT THE OCCLUSION WAS NOT RELATED TO IN-STENT THROMBOSIS. 3D ANALYSIS OF THE VESSEL SHOWED THAT THE VESSEL ANGLE WAS STRAIGHTENED BY 40 DEGREES AT 6 MONTHS AFTER THE TREATMENT. THIS ANALYSIS REVEALED THAT THE CHANGE IN VASCULAR GEOMETRY MOST LIKELY CAUSED THE KINKING AND OCCLUSION OF THE VESSEL. THE AUTHORS REPORT THAT THEY CANNOT DEFINITELY CONCLUDE THAT THE CHANGE IN VASCULAR GEOMETRY CAUSED THE IN-STENT OCCLUSION, THAT THEY CAN PRESUME THAT THE VASCULAR CHANGE CAUSED STRUCTURAL KINKING OF THE VESSEL, WHICH RESULTED IN THE IN-STENT OCCLUSION. IT IS CONSIDERED THAT VASCULAR CHANGE WAS THE MOST LIKELY CAUSE IN THIS CASE. IT WAS FURTHER REPORTED THAT THE IN-STENT OCCLUSION MAY HAVE BEEN AVOIDED IF IT HAD BEEN DEPLOYED FROM THE PROXIMAL END OF THE ACUTE BENDING PORTION OF THE VA, THUS AVOIDING KINKING OF THE VESSEL AND IN-STENT OCCLUSION. ADDITIONALLY, A SMALL VESSEL TENDS TO BE BENT MORE. THE STENT REMAINS IMPLANTED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01418934. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH (B)(6) INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(6) AND WAS DETERMINED TO BE ACCEPTABLE. IT SHOULD BE NOTED THAT THE REPORTED LOT HAS A USE BY DATE OF 2010-12, AS INDICATED IN THE DEVICE HISTORY RECORDS. THE INSTRUCTIONS FOR USE OUTLINES THAT THE ENTERPRISE VRD IS GENERALLY CONTRAINDICATED IN PATIENTS IN WHOM THE ANGIOGRAPHY DEMONSTRATES ANATOMY IS NOT APPROPRIATE FOR ENDOVASCULAR TREATMENT DUE TO SEVERE INTRACRANIAL VESSEL TORTUOSITY. BASED ON THE REPORTED INFORMATION, IT APPEARS THAT VESSEL CHARACTERISTICS AS RELATED TO THE POSITION OF THE STENT CONTRIBUTED TO THE EVENT WITH NO INDICATION OF ANY MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem · 1

THE FOLLOWING COMPLAINT DETAILS ARE FROM THE ARTICLE BY K. KONO ET AL, ¿DELAYED IN-STENT OCCLUSION DUE TO STENT-RELATED CHANGES IN VASCULAR GEOMETRY AFTER CEREBRAL ANEURYSM TREATMENT¿, NEUROL MED CHIR (TOKYO) 53, 182-185, 2013. AN INCIDENTALLY DISCOVERED UNRUPTURED ANEURYSM WITH A MAXIMUM SIZE OF 8.6 MM ON THE LEFT VERTEBRAL ARTERY (VA) REFERRED A 68 YEAR OLD MAN TO THE HOSPITAL. THE ANEURYSM WAS LOCATED PROXIMAL TO THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA). ONE WEEK BEFORE THE INTERVENTION, THE PATIENT WAS TREATED WITH 75 MG CLOPIDOGREL AND 100 MG ASPIRIN PER DAY. STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED WITH A 28MM ENTERPRISE STENT. THE STENT WAS DEPLOYED TO COVER THE NECK OF THE ANEURYSM SO THAT THE DISTAL END OF THE STENT WAS LOCATED BETWEEN THE ASA AND PICA. THE INTERVENTION WAS SUCCESSFULLY PERFORMED AND NO COMPLICATIONS OCCURRED. A SIX MONTH ANGIOGRAPHY FOLLOW-UP SHOWED IN-STENT OCCLUSION. THE LEFT VA WAS OCCLUDED FROM THE BRANCH OF THE LEFT PICA. THE DUAL ANTIPLATELET MEDICATIONS WERE CONTINUED AFTER INITIAL TREATMENT; THEREFORE THE OCCLUSION WAS NOT RELATED TO IN-STENT THROMBOSIS. 3D ANALYSIS OF THE VESSEL SHOWED THAT THE VESSEL ANGLE WAS STRAIGHTENED BY 40 DEGREES AT 6 MONTHS AFTER THE TREATMENT. THIS ANALYSIS REVEALED THAT THE CHANGE IN VASCULAR GEOMETRY MOST LIKELY CAUSED THE KINKING AND OCCLUSION OF THE VESSEL. THE PATIENT REMAINED NEUROLOGICALLY INTACT 16 MONTHS AFTER THE INTERVENTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
281900	ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM	CNV ENTERPRISE SES (NJE)	NJE	CORDIS NEUROVASCULAR, INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Life Threatening