TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
Report
- Report Number
- 1058196-2012-00137
- Event Type
- Injury
- Date Received
- March 22, 2012
- Date of Event
- May 14, 2011
- Report Date
- March 1, 2012
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- HCG
- PMA / PMN Number
- K053197
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
THE PATIENT HAS MEDICAL HISTORY OF STROKE AND COIL EMBOLIZATION FOR LEFT ICA (NO INFORMATION REGARDING THE STROKE AND THE COIL EMBOLIZATION). THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 11.5MM, AND THE NECK TO SAC RATIO WAS 11.5MM:15.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 2.8MM AND DISTALLY WAS 3.4MM. HEPARIN 12000U WAS ADMINISTERED INTRA-PROCEDURALLY. NO INFORMATION REGARDING INR, PT, AND PTT. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: (B)(6) 2011-, CLOPIDOGREL SULFATE 75MG/DAY: (B)(6) 2011-, ARGATROBAN HYDRATE 60MG/DAY: (B)(6) 2011. THE OCCLUSION RATE OF ANEURYSM WAS 100% AFTER THE PROCEDURE. PRIOR TO IMPLANTING THE VRD, SLIMGUIDE/MEDIKIT, CHIKAI/ASAHI INTECC, PROWLER SELECT PLUS MICROCATHETER (606-S255X/LOT# UNK) WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE CONSISTED OF AN EXCELSIOR SL10/STRYKER AND RADIFOCUS GT/TERUMO. FURTHER INFORMATION UNAVAILABLE AND PROCEDURAL IMAGES ARE UNAVAILABLE. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF MULTIPLE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORTS 1058196-2012-00132, 1058196-2012-00133, 1058196-2012-00134, 1058196-2012-00135, 1058196-2012-00136, 1058196-2012-00137, 1058196-2012-00138 AND 1058196-2012-00139.
ADDITIONAL MANUFACTURER NARRATIVE: Y/CORRECTED DATA: N/THE THREE YEAR FOLLOW-UP WAS CONDUCTED, MRI AND X-RAY PHOTOS EXAMINATION REVEALED THAT THE EMBOLIZED ANEURYSM HAD RE-CANALISED DUE TO COIL COMPACTION. THE CONDITION WAS DIAGNOSED AS NOT LIFE-THREATENING. THE MRS WAS 1, WHICH HAS NOT CHANGED SINCE THE 1ST YEAR FOLLOW-UP. IT IS UNKNOWN WHETHER THE COIL COMPACTION WAS IN ANY WAY RELATED TO THE PROCEDURE/DEVICES OR NOT. AS OF THE FOLLOW-UP, DAILY DOSE OF PLAVIX 75MG HAS BEEN CONTINUOUSLY ADMINISTERED. ADDITIONALLY, THE PATIENT WAS STILL SUFFERING FROM ABDUCENS PARALYSIS OF THE RIGHT EYE. THERE IS NO MORE INFORMATION AVAILABLE REGARDING THIS EVENT. THIS IS ONE OF MULTIPLE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2012-00132, 1058196-2012-00133, 1058196-2012-00134, 1058196-2012-00135, 1058196-2012-00136, 1058196-2012-00137, 1058196-2012-00138 & 1058196-2012-00139.
IT WAS REPORTED VIA THE JAPAN ENTERPRISE POST MARKET STUDY THAT THE DAY AFTER A STENT ASSISTED COIL EMBOLIZATION WHICH OF A 15MM RIGHT CAVERNOUS SINUS ANEURYSM INCLUDING THE USE OF ELEVEN TRUFILL DCS ORBIT COILS, THE PATIENT HAD ABDUCENS PARALYSIS. ACTION TAKEN WAS ADMINISTRATION OF DEXAMETHASONE. THE EVENT OUTCOME AS OF APPROXIMATELY 3 MONTHS POST EVENT WAS ¿ONGOING/IMPROVED¿. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE ENTERPRISE VRD WAS UNRELATED AND TO THE PROCEDURE WAS HIGHLY PROBABLE BECAUSE THE POSSIBLE CAUSE OF THE EVENT WAS CONSIDERED TO BE AN ANEURYSM MASS EFFECT. THE THREE YEAR FOLLOW-UP WAS CONDUCTED, MRI AND X-RAY PHOTOS EXAMINATION REVEALED THAT THE EMBOLIZED ANEURYSM HAD RE-CANALIZED DUE TO COIL COMPACTION. THE CONDITION WAS DIAGNOSED AS NOT LIFE-THREATENING. THE MRS WAS 1, WHICH HAS NOT CHANGED SINCE THE 1ST YEAR FOLLOW-UP. IT IS UNKNOWN WHETHER THE COIL COMPACTION WAS IN ANY WAY RELATED TO THE PROCEDURE/DEVICES OR NOT. AS OF THE FOLLOW-UP, DAILY DOSE OF PLAVIX 75MG HAS BEEN CONTINUOUSLY ADMINISTERED. ADDITIONALLY, THE PATIENT WAS STILL SUFFERING FROM ABDUCENS PARALYSIS OF THE RIGHT EYE. THERE IS NO MORE INFORMATION AVAILABLE REGARDING THIS EVENT. THE PATIENT HAS A MEDICAL HISTORY OF STROKE AND COIL EMBOLIZATION IN THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH NO FURTHER INFORMATION REGARDING THESE EVENTS. IT IS UNKNOWN IF THE PATIENT HAD ANY INDICATION OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. ANTIPLATELET THERAPY INCLUDED ONGOING ASPIRIN 100MG/DAY AND CLOPIDOGREL SULFATE 75MG/DAY BEGINNING THREE WEEK PRE-PROCEDURE. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 11.5MM, AND THE NECK TO SAC RATIO WAS 11.5MM: 15.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 2.8MM AND DISTALLY WAS 3.4MM. MODIFIED RANKIN SCALE (MRS) SCORE WAS TWO PRE-PROCEDURE, FIVE DAYS POST PROCEDURE AND 18 DAYS POST PROCEDURE. HEPARIN 12000U WAS ADMINISTERED INTRA-PROCEDURALLY. THE ACT WAS 151 SECONDS PRE ANTICOAGULATION AND 207 SECONDS POST ANTICOAGULATION. THERE WAS NO THROMBUS PRESENT. THE ENTERPRISE WAS IMPLANTED WITHOUT ANY DIFFICULTY AND WAS FULLY EXPANDED AND REMAINED IN A STABLE POSITION. THE IMPLANTED COILS INCLUDED 20X30 ORBIT COMPLEX STANDARD X1 (637CS2030/LOT# 15220089), 20X30 ORBIT COMPLEX STANDARD X1 (637CS2030/LOT#15251178), 18X30 ORBIT COMPLEX STANDARD X 2 (637CS1830/LOT#15121003), 18X30 ORBIT COMPLEX STANDARD X1 (638CS1830/LOT#152498361), 16X30 ORBIT COMPLEX STANDARD X1 (637CS1630/LOT# 15232686), 14X30 ORBIT COMPLEX STANDARD X1 (637CS1430/LOT# 15232315), 10X30 ORBIT COMPLEX STANDARD X3 (637CS1030/LOT# 15277890), 10X30 ORBIT COMPLEX STANDARD X1 (637CS1030/LOT # 15310810), AND ED COILS (KANEKA) X44. AFTER PLACEMENT OF THE COILS THERE WERE NO COILS PROTRUDING OUT OF THE ANEURYSM. THE OCCLUSION RATE OF ANEURYSM WAS 100% AFTER THE PROCEDURE. THERE WERE NO PROCEDURAL COMPLICATIONS CONTRIBUTING TO THE EVENT. ARGATROBAN HYDRATE 60MG/DAY WAS ADMINISTERED FOR ONE DAY BEGINNING THE DAY OF THE PROCEDURE. FURTHER INFORMATION IS UNAVAILABLE AND PROCEDURAL IMAGES ARE UNAVAILABLE. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINTS. MASS EFFECT, THE COMPRESSION OF BRAIN STRUCTURES/CRANIAL NERVES, AND RE-CANALIZATION ARE KNOWN FACTOR CONTRIBUTING TO NEUROLOGICAL SYMPTOMS. ABDUCENS PARALYSIS IS ASSOCIATED WITH CRANIAL NERVE VI WHICH RUNS IN THE CAVERNOUS SINUS BODY ADJACENT TO THE INTERNAL CAROTID ARTERY AND IS VULNERABLE TO COMPRESSIVE DISORDERS ASSOCIATED WITH THE PATIENT¿S LARGE CAVERNOUS SINUS ANEURYSM. NEUROLOGICAL DEFICITS AND INJURY TO VESSELS/TISSUE ARE KNOWN COMPLICATIONS SPECIFIC TO EMBOLIZATION PROCEDURES THAT MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. WITH REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES CONTRIBUTING TO THE EVENT. THEREFORE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF MULTIPLE PRODUCTS ASSOCIATED TO (B)(4).
PLEASE NOTE THAT FOLLOW-UP 4 SHOULD BE FOLLOW-UP 3 THAT WAS MISTAKENLY SUBMITTED WITH THE INCORRECT FOLLOW-UP NUMBER FOR ALL COMPLAINTS/REPORTS UNDER (B)(4).
IT WAS REPORTED VIA THE (B)(4) STUDY THAT THE DAY AFTER A STENT ASSISTED COIL EMBOLIZATION WHICH OF A 15MM RIGHT CAVERNOUS SINUS ANEURYSM INCLUDING THE USE OF ELEVEN TRUFILL DCS ORBIT COILS, THE PATIENT HAD ABDUCENS PARALYSIS. ACTION TAKEN WAS ADMINISTRATION OF DEXAMETHASONE. THE EVENT OUTCOME AS OF APPROXIMATELY 3 MONTHS POST EVENT WAS "ONGOING/IMPROVED." ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE ENTERPRISE VRD WAS UNRELATED AND TO THE PROCEDURE WAS HIGHLY PROBABLE BECAUSE THE POSSIBLE CAUSE OF THE EVENT WAS CONSIDERED TO BE AN ANEURYSM MASS EFFECT. THE PATIENT HAS A MEDICAL HISTORY OF STROKE AND COIL EMBOLIZATION IN THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH NO FURTHER INFORMATION REGARDING THESE EVENTS. IT IS UNKNOWN IF THE PATIENT HAD ANY INDICATION OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. ANTIPLATELET THERAPY INCLUDED ONGOING ASPIRIN 100MG/DAY AND CLOPIDOGREL SULFATE 75MG/DAY BEGINNING THREE WEEK PRE-PROCEDURE. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 11.5MM, AND THE NECK TO SAC RATIO WAS 11.5MM: 15.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 2.8MM AND DISTALLY WAS 3.4MM. MODIFIED RANKIN SCALE (MRS) SCORE WAS TWO PRE-PROCEDURE, FIVE DAYS POST PROCEDURE AND 18 DAYS POST PROCEDURE. HEPARIN 12000U WAS ADMINISTERED INTRA-PROCEDURALLY. THE ACT WAS 151 SECONDS PRE ANTICOAGULATION AND 207 SECONDS POST ANTICOAGULATION. THERE WAS NO THROMBUS PRESENT. THE ENTERPRISE WAS IMPLANTED WITHOUT ANY DIFFICULTY AND WAS FULLY EXPANDED AND REMAINED IN A STABLE POSITION. THE IMPLANTED COILS INCLUDED 20X30 ORBIT COMPLEX STANDARD X1 (637CS2030/LOT# 15220089), 20X30 ORBIT COMPLEX STANDARD X1 (637CS2030/LOT#15251178), 18X30 ORBIT COMPLEX STANDARD X 2 (637CS1830/LOT#15121003), 18X30 ORBIT COMPLEX STANDARD X1 (638CS1830/LOT#152498361), 16X30 ORBIT COMPLEX STANDARD X1 (637CS1630/LOT# 15232686), 14X30 ORBIT COMPLEX STANDARD X1 (637CS1430/LOT# 15232315), 10X30 ORBIT COMPLEX STANDARD X3 (637CS1030/LOT# 15277890), 10X30 ORBIT COMPLEX STANDARD X1 (637CS1030/LOT # 15310810), AND ED COILS (KANEKA) X44. AFTER PLACEMENT OF THE COILS, THERE WERE NO COILS PROTRUDING OUT OF THE ANEURYSM. THE OCCLUSION RATE OF ANEURYSM WAS 100% AFTER THE PROCEDURE. THERE WERE NO PROCEDURAL COMPLICATIONS CONTRIBUTING TO THE EVENT. ARGATROBAN HYDRATE 60MG/DAY WAS ADMINISTERED FOR ONE DAY BEGINNING THE DAY OF THE PROCEDURE. FURTHER INFORMATION IS UNAVAILABLE AND PROCEDURAL IMAGES ARE UNAVAILABLE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 15249836 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. MASS EFFECT, THE COMPRESSION OF BRAIN STRUCTURES/CRANIAL NERVES, IS A KNOWN FACTOR CONTRIBUTING TO NEUROLOGICAL SYMPTOMS. ABDUCENS PARALYSIS IS ASSOCIATED WITH CRANIAL NERVE VI WHICH RUNS IN THE CAVERNOUS SINUS BODY ADJACENT TO THE INTERNAL CAROTID ARTERY AND IS VULNERABLE TO COMPRESSIVE DISORDERS ASSOCIATED WITH THE PATIENT'S LARGE CAVERNOUS SINUS ANEURYSM. NEUROLOGICAL DEFICITS AND INJURY TO VESSELS/TISSUE ARE KNOWN COMPLICATIONS SPECIFIC TO EMBOLIZATION PROCEDURES THAT MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. WITH REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES CONTRIBUTING TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF MULTIPLE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORTS 1058196-2012-00132, 1058196-2012-00133, 1058196-2012-00134, 1058196-2012-00135, 1058196-2012-00136, 1058196-2012-00137, 1058196-2012-00138 AND 1058196-2012-00139.
THE REPORT FROM CLINICAL STUDY (B)(4) FOR PATIENT WITH ID (B)(6) INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH ENTERPRISE VRD (ENC452812/01425605) OF THE RIGHT CAVERNOUS SINUS, AND ONE DAY AFTER THE AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF ABDUCENS PARALYSIS. ACTION TAKEN WAS ADMINISTRATION OF DEXAMETHASONE. THE EVENT OUTCOME AS OF APPROXIMATELY THREE MONTHS AFTER ONSET WAS ONGOING, IMPROVED. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE ENTERPRISE VRD WAS UNRELATED AND TO THE PROCEDURE WAS HIGHLY PROBABLE BECAUSE THE POSSIBLE CAUSE OF THE EVENT WAS CONSIDERED TO BE AN ANEURYSM MASS EFFECT. THE COILS USED DURING THE CASE CONSISTED OF THE ORBIT RDFL COMPLEX COILS (638CS1430/15232315, 638CS1630/15232686, 638CS1830/15121003 X2, 638CS2030/15220089, 638CS1030/15277890 X3, 638CS1030/15310810, 638CS1830/15249836, 638CS2030/15251178, AND ED/KANEKA COILS X44. AFTER THE COILS WERE PLACE, NO COIL OR COILS PROTRUDED FROM THE TARGET ANEURYSM, AND NO THROMBUS WAS PRESENT DURING INITIAL ANGIOGRAPHY. NO COMPLICATIONS OCCURRED DURING THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE EVENT. DURING THE EVENT, THE ENTERPRISE STENT WAS PATENT, AND THE ENTERPRISE STENT WAS FULLY EXPANDED, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX | COMMON DEVICE: /COMMON DEVICE CODE: | HCG | CORDIS NEUROVASCULAR, INC. | NA | 15249836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |