ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM
Report
- Report Number
- 1016427-2014-00093
- Event Type
- Injury
- Date Received
- August 1, 2014
- Date of Event
- February 1, 2008
- Report Date
- July 8, 2014
- Manufacturer
- CORDIS CORPORATION
- Product Code
- NTE
- PMA / PMN Number
- K062531
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
IN ALL CASES, THE DEPLOYMENT OF A SELF-EXPANDING NITINOL STENT WAS FOLLOWED BY POSTDILATION WITH A BALLOON 5.0 TO 5.5 MM IN DIAMETER AND SHORTER THAN THE STENT. TO PREVENT BRADYCARDIA AND HYPOTENSION, INTRAVENOUS ATROPINE AND SALINE INFUSION WERE ROUTINELY ADMINISTERED PRIOR TO BALLOON DILATION. ANGIOGRAPHY WAS SYSTEMATICALLY PERFORMED TO ASSESS FLOW AFTER EACH STEP OF THE PROCEDURE: EPD PLACEMENT, BALLOON PREDILATION, STENT PLACEMENT, BALLOON POSTDILATION, AND EPD RETRIEVAL. IN THE PRESENCE OF NO FLOW IN THE ICA, ASPIRATION OF THE BLOOD COLUMN PROXIMAL TO THE FILTER WAS RECOMMENDED. AT THE COMPLETION OF THE INTERVENTION, THE FILTER DEVICE WAS RETRIEVED, AND CAROTID AND CEREBRAL FLOW WERE ASSESSED. AN OBSTRUCTION OF THE FILTER BY DEBRIS/THROMBUS WAS PRESUMED TO BE THE CAUSE OF FLOW IMPAIRMENT IF THE FILTER DEVICE REMAINED WELL EXPANDED THROUGHOUT THE PROCEDURE AND NO SEVERE SPASM OR DISSECTION COULD BE DETECTED IN THE ANGIOGRAM PRIOR TO OR DURING FLOW IMPAIRMENT AND FOLLOWING RETRIEVAL OF THE EPD. NO FLOW WAS DEFINED AS ANTEGRADE FLOW CESSATION. SLOW FLOW WAS DEFINED AS NEW AND DEFINITE FLOW IMPAIRMENT COMPARED WITH THE FLOW IN THE EXTERNAL CAROTID ARTERY. FLOW IMPAIRMENT IN THE ICA WAS OBSERVED IN 25 (22%) OF THE 115 PROCEDURES. FLOW IMPAIRMENT IN THE ICA OCCURRED MORE FREQUENTLY WITH ANGIOGUARD (22/68, 32.3%) THAN WITH THE NON-CORDIS FILTERS (2/32, 6.2%) AND (1/15, 6.7%). WITH RESPECT TO THE DEGREE OF FLOW IMPAIRMENT, SLOW FLOW OCCURRED IN 9 (13.2%) ANGIOGUARD PATIENTS. NO FLOW OCCURRED IN 13 (19.1%) PATIENTS TREATED UNDER ANGIOGUARD PROTECTION; NO PATIENTS PROTECTED WITH THE OTHER 2 DEVICES EXPERIENCED THIS EVENT. THE PRESUMED CAUSE OF FLOW IMPAIRMENT WAS PORE/ MESH OBSTRUCTION OF THE FILTER BY DEBRIS/ THROMBUS FILTER OBSTRUCTION IN 21 (18%) CASES AND FLOW-LIMITING SPASM AT THE LEVEL OF THE FILTER IN 4 (4%). NO FLOW-LIMITING DISSECTIONS WERE OBSERVED. WITH RESPECT TO THE DEGREE OF OBSTRUCTION IDENTIFIED (TABLE 1), 12 (10%) PROCEDURES WERE ASSOCIATED WITH SLOW FLOW, WHILE IN 13 (11%), COMPLETE FLOW OBSTRUCTION WAS OBSERVED. FLOW IMPAIRMENT WAS DETECTED AFTER STENTING IN 6 (24%) CASES AND AFTER BALLOON POSTDILATION OF THE STENT IN 18 (72%). IN 1 (4%) CASE, FLOW IMPAIRMENT OCCURRED AFTER BALLOON PREDILATION OF THE LESION. ALTHOUGH THE PROCEDURE WAS CONTINUED IN THE PRESENCE OF SLOW FLOW, THE BLOOD COLUMN WAS ASPIRATED WITH A CATHETER IN ALL PATIENTS WITH NO FLOW PRIOR TO EPD RETRIEVAL. THIS MANEUVER LED TO IMPROVED FLOW IN APPROXIMATELY HALF OF THE CASES IN WHICH THE FLOW WAS DOCUMENTED ON ANGIOGRAPHY AFTER ASPIRATION AND PRIOR TO FILTER REMOVAL. NORMAL FLOW WAS INVARIABLY RESTORED AFTER RETRIEVAL OF THE FILTER. PLEASE NOTE THAT THE EVENT DATE ((B)(6) 2008) WAS PROVIDED INCORRECTLY IN ORDER TO MEET ELECTRONIC MEDWATCH ACCEPTANCE REQUIREMENTS. IT IS ONLY KNOWN THAT THE ARTICLE WAS PUBLISHED IN FEBRUARY 2008; THE DAY IS CURRENTLY UNKNOWN. CONCOMITANT MEDICATIONS: HEPARIN WAS GIVEN DURING THE PROCEDURE. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. THE CATALOG CODE PROVIDED (AGXXXX), REPRESENTS AN UNKNOWN ANGIOGUARD DEVICE. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE ARE UNKNOWN. THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: ROFFI ET AL (2008). FLOW IMPAIRMENT DURING PROTECTED CAROTID ARTERY STENTING: IMPACT OF FILTER DEVICE DESIGN. J. ENDOVASCULAR THERAPY;15(1), 103-109. PLEASE NOTE THE ADVERSE EVENT OF NO FLOW REPORTED IN THIS ARTICLE OCCURRED WITH 13 PATIENTS. SINCE THERE WERE NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS, THIS EVENT WILL BE REPORTED UNDER ONE MEDICAL DEVICE REPORT (MEDWATCH). THIS IS ONE OF TWO REPORTS INVOLVED WITH THIS ARTICLE AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1016427-2014-00092 AND 1016427-2014-00093. COMPLAINT CONCLUSION: AS REPORTED IN THE PUBLICATION BY ROFFI ET AL FLOW IMPAIRMENT DURING PROTECTED CAROTID ARTERY STENTING: IMPACT OF FILTER DEVICE DESIGN, J. ENDOVASCULAR THERAPY 2008;15(1): 103-109; SLOW FLOW OCCURRED IN 9 ANGIOGUARD PATIENTS AND NO FLOW OCCURRED IN 13 PATIENTS TREATED UNDER ANGIOGUARD PROTECTION. AS FOUND IN A DATABASE ON CAS PROCEDURE, 115 (94%) PROCEDURES WERE PROTECTED WITH FILTER DEVICES. ALL PATIENTS UNDERWENT PREPROCEDURAL DUPLEX ULTRASOUND IMAGING OF THE CAROTID ARTERIES TO DETERMINE THE DEGREE OF STENOSIS. THE INDICATION FOR CAROTID REVASCULARIZATION WAS A GREATER THAN OR EQUAL TO 70% ICA STENOSIS IN ASYMPTOMATIC PATIENTS OR A GREATER THAN OR EQUAL TO 50% STENOSIS IN SYMPTOMATIC PATIENTS. THE PROCEDURAL ANTITHROMBOTIC REGIMEN CONSISTED OF UNFRACTIONATED HEPARIN DOSED TO TARGET AN ACTIVATED CLOTTING TIME (ACT) OF 250 TO 300 SECONDS. ALL PATIENTS WERE PRETREATED WITH ASPIRIN AND CLOPIDOGREL. THE PROCEDURE WAS PERFORMED USING EITHER AN 8-F GUIDE CATHETER ADVANCED OVER A 125-CM-LONG 5-F DIAGNOSTIC CATHETER WITH TELESCOPING TECHNIQUE OR A 6-F LONG SHEATH. FOLLOWING INTUBATION OF THE COMMON CAROTID ARTERY, THE LESION WAS CROSSED WITH THE EMBOLIC PROTECTION DEVICE (EPD), ANGIOGUARD FILTER OR TWO OTHER NON-CORDIS FILTERS, UNDER ROADMAP. CORRECT FILTER PLACEMENT AND APPOSITION WERE CONFIRMED BY ANGIOGRAPHY. PREDILATION WAS PERFORMED, IF NEEDED. ANGIOGRAPHY WAS SYSTEMATICALLY PERFORMED TO ASSESS FLOW AFTER EACH STEP OF THE PROCEDURE: EPD PLACEMENT, BALLOON PREDILATION, STENT PLACEMENT, BALLOON POSTDILATION, AND EPD RETRIEVAL. IN THE PRESENCE OF NO FLOW IN THE ICA, ASPIRATION OF THE BLOOD COLUMN PROXIMAL TO THE FILTER WAS RECOMMENDED. AT THE COMPLETION OF THE INTERVENTION, THE FILTER DEVICE WAS RETRIEVED, AND CAROTID AND CEREBRAL FLOW WERE ASSESSED. IN ALL CASES, THE DEPLOYMENT OF A SELF-EXPANDING NITINOL STENT WAS FOLLOWED BY POSTDILATION WITH A BALLOON 5.0 TO 5.5 MM IN DIAMETER AND SHORTER THAN THE STENT. TO PREVENT BRADYCARDIA AND HYPOTENSION, INTRAVENOUS ATROPINE AND SALINE INFUSION WERE ROUTINELY ADMINISTERED PRIOR TO BALLOON DILATION. ANGIOGRAPHY WAS SYSTEMATICALLY PERFORMED TO ASSESS FLOW AFTER EACH STEP OF THE PROCEDURE: EPD PLACEMENT, BALLOON PREDILATION, STENT PLACEMENT, BALLOON POSTDILATION, AND EPD RETRIEVAL. IN THE PRESENCE OF NO FLOW IN THE ICA, ASPIRATION OF THE BLOOD COLUMN PROXIMAL TO THE FILTER WAS RECOMMENDED. AT THE COMPLETION OF THE INTERVENTION, THE FILTER DEVICE WAS RETRIEVED, AND CAROTID AND CEREBRAL FLOW WERE ASSESSED. AN OBSTRUCTION OF THE FILTER BY DEBRIS/THROMBUS WAS PRESUMED TO BE THE CAUSE OF FLOW IMPAIRMENT IF THE FILTER DEVICE REMAINED WELL EXPANDED THROUGHOUT THE PROCEDURE AND NO SEVERE SPASM OR DISSECTION COULD BE DETECTED IN THE ANGIOGRAM PRIOR TO OR DURING FLOW IMPAIRMENT AND FOLLOWING RETRIEVAL OF THE EPD. NO FLOW WAS DEFINED AS ANTEGRADE FLOW CESSATION. SLOW FLOW WAS DEFINED AS NEW AND DEFINITE FLOW IMPAIRMENT COMPARED WITH THE FLOW IN THE EXTERNAL CAROTID ARTERY. FLOW IMPAIRMENT IN THE ICA WAS OBSERVED IN 25 (22%) OF THE 115 PROCEDURES. FLOW IMPAIRMENT IN THE ICA OCCURRED MORE FREQUENTLY WITH ANGIOGUARD (22/68, 32.3%) THAN WITH THE NON-CORDIS FILTERS (2/32, 6.2%) AND (1/15, 6.7%). WITH RESPECT TO THE DEGREE OF FLOW IMPAIRMENT, SLOW FLOW OCCURRED IN 9 (13.2%) ANGIOGUARD PATIENTS. NO FLOW OCCURRED IN 13 (19.1%) PATIENTS TREATED UNDER ANGIOGUARD PROTECTION; NO PATIENTS PROTECTED WITH THE OTHER 2 DEVICES EXPERIENCED THIS EVENT. THE PRESUMED CAUSE OF FLOW IMPAIRMENT WAS PORE/ MESH OBSTRUCTION OF THE FILTER BY DEBRIS/ THROMBUS FILTER OBSTRUCTION IN 21 (18%) CASES AND FLOW-LIMITING SPASM AT THE LEVEL OF THE FILTER IN 4 (4%). NO FLOW-LIMITING DISSECTIONS WERE OBSERVED. WITH RESPECT TO THE DEGREE OF OBSTRUCTION IDENTIFIED (TABLE 1), 12 (10%) PROCEDURES WERE ASSOCIATED WITH SLOW FLOW, WHILE IN 13 (11%), COMPLETE FLOW OBSTRUCTION WAS OBSERVED. FLOW IMPAIRMENT WAS DETECTED AFTER STENTING IN 6 (24%) CASES AND AFTER BALLOON POSTDILATION OF THE STENT IN 18 (72%). IN 1 (4%) CASE, FLOW IMPAIRMENT OCCURRED AFTER BALLOON PREDILATION OF THE LESION. ALTHOUGH THE PROCEDURE WAS CONTINUED IN THE PRESENCE OF SLOW FLOW, THE BLOOD COLUMN WAS ASPIRATED WITH A CATHETER IN ALL PATIENTS WITH NO FLOW PRIOR TO EPD RETRIEVAL. THIS MANEUVER LED TO IMPROVED FLOW IN APPROXIMATELY HALF OF THE CASES IN WHICH THE FLOW WAS DOCUMENTED ON ANGIOGRAPHY AFTER ASPIRATION AND PRIOR TO FILTER REMOVAL. NORMAL FLOW WAS INVARIABLY RESTORED AFTER RETRIEVAL OF THE FILTER. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. HYPOPERFUSION (ALSO KNOWN AS FLOW IMPAIRMENT) IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENTING PROCEDURE WITH THE USE OF AN ANGIOGUARD DEVICE AND IS LISTED IN THE IFU AS SUCH. THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES DURING A STENTING PROCEDURE PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT IS INTENDED TO BE COLLECTED IN THE EMBOLIC PROTECTION DEVICE BOTH DURING AND AFTER CAROTID STENT IMPLANTATION. IF ENOUGH DEBRIS IS COLLECTED IN THE EMBOLIC PROTECTION DEVICE, IT MAY LEAD TO HYPOPERFUSION WITH OR WITHOUT THE ACCOMPANIMENT OF NEUROLOGICAL SYMPTOMS. THE IFU STATES ¿IF THERE IS A SEVERE REDUCTION IN DISTAL DYE PERFUSION, IT IS RECOMMENDED TO EXCHANGE THE ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE FOR A NEW ONE.¿ THIS CATHETER EXCHANGE OR REMOVAL IS A RECOMMENDED PART OF THE PROCEDURE AND DOES NOT REPRESENT A DEVICE MALFUNCTION OR AN ADDITIONAL INTERVENTION. AS STATED IN THE ARTICLE, ¿NORMAL FLOW WAS INVARIABLY RESTORED AFTER RETRIEVAL OF THE FILTER.¿ BASED ON THE AVAILABLE INFORMATION REPORTED IN THE ARTICLE, LESION AND VESSEL CHARACTERISTICS LIKELY CONTRIBUTED TO THE HYPOPERFUSION EVENTS. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A DESIGN OR MANUFACTURING ISSUE, THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
AS REPORTED IN THE PUBLICATION BY ROFFI ET AL FLOW IMPAIRMENT DURING PROTECTED CAROTID ARTERY STENTING: IMPACT OF FILTER DEVICE DESIGN, J. ENDOVASCULAR THERAPY 2008;15(1): 103-109; SLOW FLOW OCCURRED IN 9 ANGIOGUARD PATIENTS AND NO FLOW OCCURRED IN 13 PATIENTS TREATED UNDER ANGIOGUARD PROTECTION. AS FOUND IN A DATABASE ON CAS PROCEDURE, 115 (94%) PROCEDURES WERE PROTECTED WITH FILTER DEVICES. ALL PATIENTS UNDERWENT PREPROCEDURAL DUPLEX ULTRASOUND IMAGING OF THE CAROTID ARTERIES TO DETERMINE THE DEGREE OF STENOSIS. THE INDICATION FOR CAROTID REVASCULARIZATION WAS A GREATER THAN OR EQUAL TO 70% ICA STENOSIS IN ASYMPTOMATIC PATIENTS OR A GREATER THAN OR EQUAL TO 50% STENOSIS IN SYMPTOMATIC PATIENTS. THE PROCEDURAL ANTITHROMBOTIC REGIMEN CONSISTED OF UNFRACTIONATED HEPARIN DOSED TO TARGET AN ACTIVATED CLOTTING TIME (ACT) OF 250 TO 300 SECONDS. ALL PATIENTS WERE PRETREATED WITH ASPIRIN AND CLOPIDOGREL. THE PROCEDURE WAS PERFORMED USING EITHER AN 8-F GUIDE CATHETER ADVANCED OVER A 125-CM-LONG 5-F DIAGNOSTIC CATHETER WITH TELESCOPING TECHNIQUE OR A 6-F LONG SHEATH. FOLLOWING INTUBATION OF THE COMMON CAROTID ARTERY, THE LESION WAS CROSSED WITH THE EMBOLIC PROTECTION DEVICE (EPD), ANGIOGUARD FILTER OR TWO OTHER NON-CORDIS FILTERS, UNDER ROADMAP. CORRECT FILTER PLACEMENT AND APPOSITION WERE CONFIRMED BY ANGIOGRAPHY. PREDILATION WAS PERFORMED, IF NEEDED. ANGIOGRAPHY WAS SYSTEMATICALLY PERFORMED TO ASSESS FLOW AFTER EACH STEP OF THE PROCEDURE: EPD PLACEMENT, BALLOON PREDILATION, STENT PLACEMENT, BALLOON POSTDILATION, AND EPD RETRIEVAL. IN THE PRESENCE OF NO FLOW IN THE ICA, ASPIRATION OF THE BLOOD COLUMN PROXIMAL TO THE FILTER WAS RECOMMENDED. AT THE COMPLETION OF THE INTERVENTION, THE FILTER DEVICE WAS RETRIEVED, AND CAROTID AND CEREBRAL FLOW WERE ASSESSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451204 | ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE SYSTEM | EMBOLIC PROTECTION DEVICE | NTE | CORDIS CORPORATION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | UNKNOWN CAROTID STENT |