STENT - VASCULAR RECONSTRUCTION
Report
- Report Number
- 1226348-2018-00616
- Event Type
- Death
- Date Received
- June 22, 2018
- Date of Event
- March 31, 2015
- Report Date
- April 5, 2018
- Manufacturer
- CODMAN AND SHURTLEFF, INC
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4). THIS LITERATURE ARTICLE AND SUBSEQUENT COMPLAINT WAS FOUND DURING A RECENT POST-MARKET SURVEILLANCE REVIEW (PMS) OF THIS DEVICE. THE CITATION IS AS FOLLOWS: WORLD NEUROSURG. (2018) 113:26-32 HTTPS://DOI.ORG/10.1016/J.WNEU.2018.01.014. ¿ENDOVASCULAR PATCH EMBOLIZATION FOR BLOOD BLISTER¿LIKE ANEURYSMS IN DORSAL SEGMENT OF INTERNAL CAROTID ARTERY¿ XUDONG HAO-GUILIN LI-JIAN REN-JINGWEI LI-CHUAN HE-HONG-QI ZHANG - WORLD NEUROSURGERY ¿ 2018. THIS MDR REPORT IS BEING SUBMITTED WITH NO PATIENT DEMOGRAPHICS; THERE WAS NO DEVICE SPECIFIC INFORMATION (INCLUDING DEVICE CATALOG AND LOT NUMBER) PROVIDED IN THE ARTICLE. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE WAS NOT RETURNED FOR ANALYSIS NOR WERE THE STERILE LOT NUMBER PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. (B)(6). [CONCLUSION]: THE REPORTED VASOSPASM EVENT WAS CAPTURED IN THE LITERATURE STUDY, ¿ENDOVASCULAR PATCH EMBOLIZATION FOR BLOOD BLISTER¿LIKE ANEURYSMS IN DORSAL SEGMENT OF INTERNAL CAROTID ARTERY¿ XUDONG HAO-GUILIN LI-JIAN REN-JINGWEI LI-CHUAN HE-HONG-QI ZHANG - WORLD NEUROSURGERY ¿ 2018. THE PURPOSE OF THE STUDY WAS TO REPORT CLINICAL AND ANGIOGRAPHIC RESULTS WITH PROCEDURAL DETAILS FOR THE TREATMENT OF BLOOD BLISTER-LIKE ANEURYSM (BBA) BY USING THE ENDOVASCULAR PATCH EMBOLIZATION METHOD. BLOOD BLISTER-LIKE ANEURYSM IN THE INTERNAL CAROTID ARTERY (ICA) IS A SPECIAL TYPE OF RUPTURED ANEURYSM THAT ORIGINATES FROM THE DORSAL SEGMENT OF THE ICA; IT IS DIFFERENT FROM A TRUE ANEURYSM. BBAS ARE CHARACTERIZED BY A LOSS OF INTERNAL ELASTIC LAMINA, VASCULAR INTIMA, AND MEDIA. THEY ARE PSEUDOANEURYSMS THAT POSSESS ONLY A FRAGILE FIBROUS LAYER. THESE SPECIAL PATHOLOGIC CHARACTERISTICS OF BBAS LEAD TO THEIR RAPID ENLARGEMENT IN A SHORT TIME WITH A HIGH RISK OF RE-RUPTURE. BBAS IN THE DORSAL SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) ARE FRAGILE AND DIFFICULT TO TREAT. THE FRAGILE FIBROUS LAYER CANNOT PROVIDE ENOUGH SUPPORT TO ENSURE THE STABILITY OF THE COILS INSIDE THE ANEURYSM. CHARACTERISTICS OF THE BBAS INDICATE THAT TWO POINTS NEED TO BE CONSIDERED DURING ENDOVASCULAR TREATMENT. THE FIRST POINT IS INCREASING THE BLOOD FLOW GUIDANCE TO REDUCE THE DYNAMIC IMPACT OF BLOOD FLOW ON ANEURYSMS. THE SECOND POINT IS THAT COILS IN THE ANEURYSM SAC SHOULD ALSO BE ANCHORED TO STRENGTHEN THEIR STABILITY AND ABILITY TO RESIST FLOW IMPACT. IN USING THE ENDOVASCULAR PATCH TECHNIQUE, STENTS CAN BE GRADUALLY AND PRECISELY DEPLOYED. A WEDGE-SHAPED SPACE IS FORMED BETWEEN THE PARENT ARTERY AND THE STENT. WITH THE SWAYING OF THE MICROCATHETER, THE COIL CAN BE PRECISELY EMBOLIZED IN THE ANEURYSM SAC AND THE CREATED WEDGE-SHAPED SPACE TO ACHIEVE A COMPACT EMBOLIZATION IN THE ANEURYSM AND LOOSE EMBOLIZATION IN THE PARENT ARTERY NEAR THE ANEURYSM NECK. THE COILS CAN BE FIXED BETWEEN THE STENT AND PARENT ARTERY AFTER COMPLETE STENT DEPLOYMENT. AN ENDOVASCULAR PATCH IS FORMED AND ANCHORED BETWEEN THE STENT AND PARENT ARTERY AROUND THE ANEURYSM NECK. THIS IS THE KEY FEATURE OF THIS METHOD OF TREATMENT. THE COIL AROUND THE ANEURYSM NECK ALSO PROVIDES AN ANCHORING EFFECT TO STABILIZE THE COIL INSIDE THE ANEURYSM. THE PROBABILITY OF A THROMBOEMBOLISM IS HIGHER DUE TO PART OF THE COIL BEING BETWEEN THE STENT AND THE WALL OF THE BLOOD VESSEL. ANTIPLATELET AGGREGATION THERAPY IS REQUIRED BEFORE THE PROCEDURE TO PREVENT COMPLICATIONS OF ARTERIAL THROMBOSIS. THE LITERATURE STUDY PRESENTS A RETROSPECTIVE REVIEW OF 8 PATIENTS: 3 MALES AND 5 FEMALES (AGE RANGE FROM 30 TO 60 YEARS OLD; AVERAGE 49.5 YEARS OLD WHO PRESENTED WITH SUBARACHNOID HEMORRHAGE (SAH) CAUSED BY INTERNAL CAROTID ARTERY-BBAS AND WERE TREATED WITH THE ENDOVASCULAR PATCH EMBOLIZATION TECHNIQUE FROM OCTOBER 2011 TO MARCH 2015. PATIENTS¿ INITIAL CLINICAL STATES WERE EVALUATED USING THE HUNT-HESS GRADING SYSTEM. ALL PATIENTS WERE GIVEN LOADING DOSES OF 300 MG OF ASPIRIN AND 300 MG OF CLOPIDOGREL ORALLY 2 HOURS PRIOR TO THE PROCEDURE. ROUTINE HEPARIN WAS ADMINISTERED DURING THE PROCEDURE. POST-PROCEDURE ROUTINE ASPIRIN (100 MG) AND CLOPIDOGREL (75 MG) WERE PROVIDED FOR AT LEAST 3 MONTHS. THE EVENT REPORTED IS THAT PATIENT 4 PRESENTED WITH AN IRREGULAR SHAPED ANEURYSM OF THE FOLLOWING SIZE: 4.2 MM X 3.9 MM X 2.3 MM WITH AN INITIAL CLINICAL STATE HUNT-HESS GRADE V SUBARACHNOID HEMORRHAGE WAS TREATED 4 DAYS AFTER THE ANEURYSM HEMORRHAGE ONSET WITH A SINGLE ENTERPRISE 4.5 MM X 14 MM STENT AND COILING THAT RESULTED IN IMMEDIATE TOTAL OCCLUSION. THE DAY AFTER THE ENDOVASCULAR TREATMENT, PATIENT 4 PRESENTED WITH SEVERE VASOSPASM. IT WAS CAPTURED IN THE LITERATURE ARTICLE THAT VASOSPASM WAS DUE TO THE EXCESSIVE OPERATION OF THE BLOOD VESSELS AND THE LARGE AMOUNT OF BLOOD LOSS IN THE SUBARACHNOID CAVITY. THERE WERE NO SIGNS OF REBLEEDING OR ANEURYSMAL RELAPSE DURING FOLLOW-UP. FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED THAT PARENT ARTERIES REMAINED PATENT WITH NO OBVIOUS STENOSIS OBSERVED. THE LITERATURE STUDY DOCUMENTED THAT PATIENT DIED 4 MONTHS AFTER THE TREATMENT OF MULTIPLE ORGAN FAILURE. NO ADDITIONAL INFORMATION ABOUT THE PATIENT, PROCEDURE OR DEVICE (INCLUDING CATALOG AND LOT NUMBER) WAS PROVIDED IN THE ARTICLE. THE ENTERPRISE STENT REMAIN IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE STERILE LOT NUMBER IS NOT KNOWN. NO FURTHER ANALYSIS CAN BE PERFORMED FOR COMPLAINTS REPORTED WITHOUT A LOT NUMBER AND FOR WHICH THE ASSOCIATED PRODUCTS WILL NOT BE RETURNED. VASOSPASM IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE ENTERPRISE STENT AND STENTING PROCEDURES. THE ROOT CAUSE OF THE EVENT APPEARS TO BE RELATED BY THE EXCESSIVE MANIPULATION OF BLOOD VESSELS AND PRE-EXISTING HEMORRHAGE AS REPORTED BY THE AUTHOR. AS DOCUMENTED IN THE MEDICAL LITERATURE, FOLLOWING SUBARACHNOID HEMORRHAGE FROM A RUPTURED BRAIN ANEURYSM, VASOSPASM CAN OCCUR IN UP TO 70% OF CASES. THE HIGHEST PERIOD OF RISK IS 7-10 DAYS FOLLOWING THE BLEED, BUT CAN OCCUR AT ANY TIME FROM 3-15 DAYS AFTER THE RUPTURED ANEURYSM. SINCE VASOSPASM CAN RESULT IN DEATH AND IS MOST OFTEN TREATED, IT MEETS MDR REPORTING CRITERIA AS A SERIOUS INJURY. SINCE THE CAUSE OF DEATH 4 MONTHS AFTER THE PROCEDURE WAS RELATED TO A MEDICAL CONDITION (MULTI-ORGAN FAILURE), IT WILL NOT BE CONSIDERED AND EVENT ASSOCIATED WITH THE ENTERPRISE STENT. THE STUDY CONCLUDES THAT BBAS ARE A SPECIAL TYPE OF ANEURYSM. HEMODYNAMIC IMPACT AND LACK OF SUPPORT FOR THE EMBOLIC CONTENT BY THE THIN ANEURYSM WALL CONTRIBUTE TO THE HIGH RISK OF TREATMENT. THE ENDOVASCULAR PATCH TECHNIQUE ENABLES BOTH BLOOD FLOW GUIDANCE AND STABILIZATION OF EMBOLIC MATERIAL AND THEREFORE MAY BE USED TO ACHIEVE EFFECTIVE AND SAFE RESULTS. THERE ARE LIMITATIONS TO THIS STUDY WHICH INCLUDES ONLY A SMALL NUMBER OF PATIENTS AND THE SAFETY AND EFFICACY OF THIS TECHNIQUE NEEDS TO BE CONFIRMED BY A COHORT STUDY. THE ENDOVASCULAR PATCH TECHNIQUE NEEDS MORE SKILL THAN THE TRADITIONAL STENT-ASSISTED EMBOLIZATION OR FLOW DIVERTER IMPLANTATION. THUS, THE RISK OF INTRAOPERATION RUPTURE OR POST-OPERATION THROMBOEMBOLISM, MAY BE HIGHER. 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.
THIS EVENT INVOLVED A DEATH AND THOSE FIELDS WERE ACCIDENTALLY OMITTED. THEY HAVE BEEN ADDED IN THIS REPORT TO REFLECT THE DEATH EVENT. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. (B)(4).
THE REPORTED VASOSPASM EVENT WAS CAPTURED IN THE LITERATURE STUDY, ¿ENDOVASCULAR PATCH EMBOLIZATION FOR BLOOD BLISTER¿LIKE ANEURYSMS IN DORSAL SEGMENT OF INTERNAL CAROTID ARTERY¿ XUDONG HAO-GUILIN LI-JIAN REN-JINGWEI LI-CHUAN HE-HONG-QI ZHANG - WORLD NEUROSURGERY ¿ 2018. PATIENT 4 PRESENTED WITH AN IRREGULAR SHAPED ANEURYSM OF THE FOLLOWING SIZE: 4.2 MM X 3.9 MM X 2.3 MM WITH AN INITIAL CLINICAL STATE HUNT-HESS GRADE V SUBARACHNOID HEMORRHAGE WAS TREATED 4 DAYS AFTER THE ANEURYSM HEMORRHAGE ONSET WITH A SINGLE ENTERPRISE 4.5 MM X 14 MM STENT AND COILING THAT RESULTED IN IMMEDIATE TOTAL OCCLUSION. THE DAY AFTER THE ENDOVASCULAR TREATMENT, PATIENT 4 PRESENTED WITH SEVERE VASOSPASM. IT WAS CAPTURED IN THE LITERATURE ARTICLE THAT VASOSPASM WAS DUE TO THE EXCESSIVE OPERATION OF THE BLOOD VESSELS AND THE LARGE AMOUNT OF BLOOD LOSS IN THE SUBARACHNOID CAVITY. THERE WERE NO SIGNS OF REBLEEDING OR ANEURYSMAL RELAPSE DURING FOLLOW-UP. FOLLOW-UP DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED THAT PARENT ARTERIES REMAINED PATENT WITH NO OBVIOUS STENOSIS OBSERVED. THE LITERATURE STUDY DOCUMENTED THAT PATIENT DIED 4 MONTHS AFTER THE TREATMENT OF MULTIPLE ORGAN FAILURE. NO ADDITIONAL INFORMATION ABOUT THE PATIENT, PROCEDURE OR DEVICE (INCLUDING CATALOG AND LOT NUMBER) WAS PROVIDED IN THE ARTICLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471836 | STENT - VASCULAR RECONSTRUCTION | INTRACRANIAL NEUROVASCULAR STENT | NJE | CODMAN AND SHURTLEFF, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |