ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2014-00078
- Event Type
- Injury
- Date Received
- March 15, 2014
- Date of Event
- September 22, 2013
- Report Date
- February 21, 2014
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
THE CATALOG AND LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, THEREFORE, THE DEVICE UNKENTERPRISEENC REPRESENTS AN ENTERPRISE VRD THAT THE CATALOG NUMBER BEGINS WITH ENC. (B)(4). THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS REPORTED UNDER (B)(4).
AS REPORTED VIA A LITERATURE ARTICLE (GONZALEZ, ANA MARCOS, ET AL. ¿BLOOD BLISTER-LIKE ANEURYSMS: SINGLE CENTER EXPERIENCE AND SYSTEMATIC LITERATURE REVIEW¿ ,EUROPEAN JOURNAL OF RADIOLOGY, (2014): 197-205) A PATIENT (PATIENT #5) THERE WAS PERSISTENT ANEURYSM EVOLUTION FOLLOWING PLACEMENT OF MULTI-LAYER ENTERPRISE STENTS (LOT AND CATALOG NUMBERS UNKNOWN) AND UNKNOWN COILS FOR TREATMENT OF RIGHT INTERNAL CAROTID ARTERY BLOOD BLISTER-LIKE ANEURYSM WITH SUBARACHNOID HEMORRHAGE. THIS WAS SUCCESSFULLY TREATED WITH PLACEMENT OF COILS. UNKNOWN DATE: THE CT AND CT ANGIOGRAM FROM THE ER DIAGNOSED SAH, CAUSED BY THE RUPTURE OF A SMALL ANEURYSM IN THE RIGHT ICA, AND HYDROCEPHALUS. ADDITIONAL INFORMATION PROVIDED INDICATED THAT ¿AS THE TEXT MENTIONS, IT IS A VERY COMPLEX TYPE OF ANEURYSM. THE ENTERPRISE STENT DID VERY WELL THE JOB AND WE HAD TO RETREAT THE PATIENT DUE TO A VASOSPASM AND WE DECIDED TO ADD MORE COILS TO THE ANEURYSM SAC. THE MEDICATION IS MARKED ON THE TEXT BELOW PLAVIX AND ASPIRIN. THE ANEURYSM HAD 3 X 3 X 3.4 MM AND THE VESSELS RANGED FROM 4 TO 4,2 MM. WE HAVE NO REFERENCES OF THE DEVICES USED AT THE TIME OF THE PROCEDURE. THE ENTERPRISE STENT DID VERY WELL THE JOB AND WE HAD TO RETREAT THE PATIENT DUE TO A VASOSPASM AND WE DECIDED TO ADD MORE COILS TO THE ANEURYSM SAC. THE MEDICATION IS MARKED ON THE TEXT BELOW PLAVIX AND ASPIRIN. THE ANEURYSM HAD 3 X 3 X 3.4 MM AND THE VESSELS RANGED FROM 4 TO 4,2 MM. THERE WERE NO REFERENCES OF THE DEVICES USED AT THAT TIME ((B)(6) 2008). THE ENTERPRISE VRD¿S REMAINED IMPLANTED AND THE LOT NUMBERS ARE NOT KNOWN; THEREFORE, THE DEVICE HISTORY RECORD REVIEWS CANNOT BE COMPLETED. THE PATIENT¿S BASELINE PRESENTATION, PRESENCE OF SUB-ARACHNOID HEMORRHAGE USING MULTIPLE MODALITIES ARE ALL FACTORS POSSIBLY IMPACTING THE OUTCOME ASSOCIATED WITH THE OFF-LABEL USE OF THE ENTERPRISE VRD. ALTHOUGH, NO DEFINITIVE CONCLUSION CAN BE MADE, BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING OR PERFORMANCE ISSUES RELATED TO THE PATIENT PROCEDURAL OUTCOME AND SUBSEQUENT DEATH. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4).
AS REPORTED VIA A LITERATURE ARTICLE (GONZALEZ, ANA MARCOS, ET AL. ¿BLOOD BLISTER-LIKE ANEURYSMS: SINGLE CENTER EXPERIENCE AND SYSTEMATIC LITERATURE REVIEW¿ ,EUROPEAN JOURNAL OF RADIOLOGY, (2014): 197-205) A PATIENT (PATIENT #5) THERE WAS PERSISTENT ANEURYSM EVOLUTION FOLLOWING PLACEMENT OF MULTI-LAYER ENTERPRISE STENTS (LOT AND CATALOG NUMBERS UNKNOWN) AND UNKNOWN COILS FOR TREATMENT OF RIGHT INTERNAL CAROTID ARTERY BLOOD BLISTER-LIKE ANEURYSM WITH SUBARACHNOID HEMORRHAGE. THIS WAS SUCCESSFULLY TREATED WITH PLACEMENT OF COILS. HISTORY: HYPERTENSION
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155216 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |