ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

Report

Report Number: 1226348-2017-00152
Event Type: Malfunction
Date Received: September 15, 2017
Date of Event: November 4, 2011
Report Date: August 24, 2017
Manufacturer: CODMAN AND SHURTLEFF, INC
Product Code: NJE
PMA / PMN Number: H60001
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCT: PROWLER SELECT PLUS MICROCATHETER, SYNCHRO-2 MICROWIARE, PROTEGE 8MM TO 6MM TAPERED STENT. ARTICLE ATTACHED TO THE MDR: RAHAL, J.P., GAO, B., GAO, B. ET AL. (2014). STENT RECANALIZATION OF CAROTID TONSILLAR LOOP DISSECTION USING THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE. JOURNAL OF CLINICAL NEUROSCIENCE 21 (2014) 1141¿1147. THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS. THESE ARTICLES ARE BEING REVIEWED MONTHLY FOR SAFETY SIGNALS AND WILL BE FOLLOWED BY MONTHLY TRENDING ASSESSMENTS AS WELL AS PMS REVIEWS. DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER COULD NOT BE OBTAINED FROM THE AUTHOR. UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT PART NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCLUSION: IN THE LITERATURE ARTICLE ¿STENT RECANALIZATION OF CAROTID TONSILLAR LOOP DISSECTION USING THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE¿ BY JASON P. RAHAL, BULANG GAO, MINA G. SAFAIN, ADEL M. MALEK, PUBLISHED JOURNAL OF CLINICAL NEUROSCIENCE 21 (2014) 1141¿1147, IT WAS REPORTED THAT PATIENT # 4 HAD INCOMPLETE STENT EXPANSION AFTER AN OFF-LABEL USE OF AN UNKNOWN ENTERPRISE STENT. PER THE ARTICLE: ¿A (B)(6) RIGHT-HANDED WOMAN PRESENTED TO A COMMUNITY HOSPITAL WITH LEFT-SIDED HAND, ARM AND LEG CLUMSINESS, DYSARTHRIA LASTING ABOUT 20 MINUTES, AND RIGHT-SIDED NECK AND EAR PAIN 10 DAYS AFTER A MOTOR VEHICLE ACCIDENT. MRI AND MRA SHOWED RIGHT FRONTAL ACUTE AND SUBACUTE INFARCTS AND BILATERAL CERVICAL ICA DISSECTIONS. SHE WAS PLACED ON HEPARIN AND PRE-MEDICATED WITH ASPIRIN AND CLOPIDOGREL FOR 3 DAYS. BECAUSE OF THE BILATERAL PATHOLOGY, ANGIOGRAPHIC EVALUATION WAS RECOMMENDED. INJECTION OF THE RIGHT ICA DEMONSTRATED DISSECTION OF THE CERVICAL SEGMENT EXTENDING FROM THE CAROTID BULB THROUGH A TONSILLAR LOOP WITH NO DISTAL FLOW. LEFT ICA INJECTION DEMONSTRATED A NONFLOW- LIMITING DISSECTION WITH A PSEUDOANEURYSM. GIVEN THE PATIENT HAD AN OCCLUSIVE DISSECTION ON THE RIGHT AND A STENOTIC LESION ON THE LEFT, THE RISK FOR PROGRESSION OF HER INFARCTS WAS CONSIDERED HIGH AND THE DECISION WAS MADE TO ATTEMPT ENDOVASCULAR RECONSTRUCTION OF THE RIGHT-SIDED DISSECTION. A PROWLER SELECT PLUS MICROCATHETER GUIDED WITH A SYNCHRO-2 MICROWIRE WAS USED TO ACCESS THE TRUE LUMEN OF THE RIGHT ICA DISSECTION AND CROSS THE DISTAL TORTUOUS TONSILLAR SEGMENT. THEN A 37 MM X 4.5 MM ENTERPRISE STENT WAS DEPLOYED ACROSS THIS SEGMENT FOLLOWED IN TANDEM WITH A PROXIMALLY PLACED PROTÉGÉ 8 MM TO 6 MM TAPERED STENT ACROSS THE DISSECTION INFLOW ZONE. THIS RESTORED FLOW ACROSS THE DISSECTION, WITH A SMALL AREA OF RESIDUAL STENOSIS AT THE PROXIMAL END OF THE TONSILLAR LOOP. THE TONSILLAR LOOP IN THIS CASE WAS VERY TIGHTLY WOUND MAKING A CORKSCREW TURN. THE ENTERPRISE STENT ENDED AT THE PROXIMAL END OF THE TURN AND THE OPENING FORCE OF THE STENT WAS NOT SUFFICIENT TO KEEP THE TRUE LUMEN COMPLETELY OPEN. HER 3-MONTH FOLLOW-UP ANGIOGRAPHY DEMONSTRATED SLIGHT NARROWING OF THE VESSEL LUMEN DUE TO PROGRESSIVE COLLAPSE OF THE TWISTED STENT TINES. FURTHER INTERVENTION WAS DEEMED HIGH RISK, AS BALLOON ANGIOPLASTY WITHIN THE KINKED STENT CARRIED THE RISK OF CATCHING THE STENT TINES WITH THE BALLOON. AT HER 24-MONTH CLINICAL FOLLOW-UP, THE PATIENT HAD RECOVERED COMPLETELY. NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, WAS PROVIDED IN THE ARTICLE. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. IN ADDITION, A LOT NUMBER COULD NOT BE OBTAINED; THEREFORE, A DHR COULD NOT BE PERFORMED FOR THE DEVICE. THE INABILITY OF THE ENTERPRISE STENT TO FULLY EXPAND COULD NOT BE CONFIRMED WITHOUT PRODUCT RETURN OR FILMS TO VERIFY THE EVENT. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, VESSEL CHARACTERISTICS (CORKSCREW TURN) AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THE USE OF THE DEVICE WAS OFF-LABEL. THE INSTRUCTIONS FOR USE (IFU) STATES ¿THE CODMAN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM IS INTENDED FOR USE WITH EMBOLIC COILS FOR THE TREATMENT OF WIDE-NECK, INTRACRANIAL, SACCULAR OR FUSIFORM ANEURYSM ARISING FROM A PARENT VESSEL¿. ALSO THE IFU CAUTIONS THAT THE DEVICE ¿IS NOT INTENDED FOR USE AS A STAND-ALONG DEVICE¿, AND ¿PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPING STENTS HAS NOT BEEN ESTABLISHED¿. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem · 1

IN THE LITERATURE ARTICLE ¿STENT RECANALIZATION OF CAROTID TONSILLAR LOOP DISSECTION USING THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE¿ BY JASON P. RAHAL, BULANG GAO, MINA G. SAFAIN, ADEL M. MALEK, PUBLISHED JOURNAL OF CLINICAL NEUROSCIENCE 21 (2014) 1141¿1147, IT WAS REPORTED THAT PATIENT # 4 HAD INCOMPLETE STENT EXPANSION AFTER AN OFF-LABEL USE OF AN UNKNOWN ENTERPRISE STENT. PER THE ARTICLE: ¿A (B)(6) YEAR-OLD RIGHT-HANDED WOMAN PRESENTED TO A COMMUNITY HOSPITAL WITH LEFT-SIDED HAND, ARM AND LEG CLUMSINESS, DYSARTHRIA LASTING ABOUT 20 MINUTES, AND RIGHT-SIDED NECK AND EAR PAIN 10 DAYS AFTER A MOTOR VEHICLE ACCIDENT. MRI AND MRA SHOWED RIGHT FRONTAL ACUTE AND SUBACUTE INFARCTS AND BILATERAL CERVICAL ICA DISSECTIONS. SHE WAS PLACED ON HEPARIN AND PRE-MEDICATED WITH ASPIRIN AND CLOPIDOGREL FOR 3 DAYS. BECAUSE OF THE BILATERAL PATHOLOGY, ANGIOGRAPHIC EVALUATION WAS RECOMMENDED. INJECTION OF THE RIGHT ICA DEMONSTRATED DISSECTION OF THE CERVICAL SEGMENT EXTENDING FROM THE CAROTID BULB THROUGH A TONSILLAR LOOP WITH NO DISTAL FLOW. LEFT ICA INJECTION DEMONSTRATED A NONFLOW- LIMITING DISSECTION WITH A PSEUDOANEURYSM. GIVEN THE PATIENT HAD AN OCCLUSIVE DISSECTION ON THE RIGHT AND A STENOTIC LESION ON THE LEFT, THE RISK FOR PROGRESSION OF HER INFARCTS WAS CONSIDERED HIGH AND THE DECISION WAS MADE TO ATTEMPT ENDOVASCULAR RECONSTRUCTION OF THE RIGHT-SIDED DISSECTION. A PROWLER SELECT PLUS MICROCATHETER GUIDED WITH A SYNCHRO-2 MICROWIRE WAS USED TO ACCESS THE TRUE LUMEN OF THE RIGHT ICA DISSECTION AND CROSS THE DISTAL TORTUOUS TONSILLAR SEGMENT. THEN A 37 MM X 4.5 MM ENTERPRISE STENT WAS DEPLOYED ACROSS THIS SEGMENT FOLLOWED IN TANDEM WITH A PROXIMALLY PLACED PROTÉGÉ 8 MM TO 6 MM TAPERED STENT ACROSS THE DISSECTION INFLOW ZONE. THIS RESTORED FLOW ACROSS THE DISSECTION, WITH A SMALL AREA OF RESIDUAL STENOSIS AT THE PROXIMAL END OF THE TONSILLAR LOOP. THE TONSILLAR LOOP IN THIS CASE WAS VERY TIGHTLY WOUND MAKING A CORKSCREW TURN. THE ENTERPRISE STENT ENDED AT THE PROXIMAL END OF THE TURN AND THE OPENING FORCE OF THE STENT WAS NOT SUFFICIENT TO KEEP THE TRUE LUMEN COMPLETELY OPEN. HER 3-MONTH FOLLOW-UP ANGIOGRAPHY DEMONSTRATED SLIGHT NARROWING OF THE VESSEL LUMEN DUE TO PROGRESSIVE COLLAPSE OF THE TWISTED STENT TINES. FURTHER INTERVENTION WAS DEEMED HIGH RISK, AS BALLOON ANGIOPLASTY WITHIN THE KINKED STENT CARRIED THE RISK OF CATCHING THE STENT TINES WITH THE BALLOON. AT HER 24-MONTH CLINICAL FOLLOW-UP, THE PATIENT HAD RECOVERED COMPLETELY. NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, WAS PROVIDED IN THE ARTICLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
649323	ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM	INTRACRANIAL NEUROVASCULAR STENT	NJE	CODMAN AND SHURTLEFF, INC	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR