UNKNOWN BX VELOCITY OUS

Report

Report Number: 9616099-2017-01644
Event Type: Injury
Date Received: December 1, 2017
Date of Event: October 11, 2017
Report Date: December 1, 2017
Manufacturer: CORDIS CASHEL
Product Code: MAF
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: HADA, Y., FUJII, H., SHIMIZU, M., YAMAWAKE, N., & NISHIZAKI, M. (2017). EFFECTIVENESS OF BARE METAL STENT IMPLANTATION FOR THE TREATMENT OF CORONARY ARTERY ANEURYSM: A MULTIMODALITY IMAGING EVALUATION. INTERNAL MEDICINE. DOI:10.2169/INTERNALMEDICINE.8532-16. COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE PUBLICATION BY HADA ET AL EFFECTIVENESS OF BARE METAL STENT IMPLANTATION FOR THE TREATMENT OF CORONARY ARTERY ANEURYSM: A MULTIMODALITY IMAGING EVALUATION, INTERN MED. (B)(6) 2017, IN (B)(6) 2007, A (B)(6) MAN WAS ADMITTED WITH EFFORT ANGINA. THE PATIENTS¿ CORONARY RISK FACTORS WERE HYPERTENSION, DYSLIPIDEMIA, OBESITY AND SMOKING. THE PATIENT HAD UNDERGONE BARE METAL STENT (BMS) IMPLANTATION (BX VELOCITY: 3.5 IN DIAMETER, 28 MM IN LENGTH) FOR PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) 2 YEARS PREVIOUSLY. CORONARY ANGIOGRAPHY (CAG) REVEALED SEVERE STENOSIS OF THE MID LAD. INTRAVASCULAR ULTRASOUND (IVUS) REVEALED SEVERE NEGATIVE REMODELING AT THE CULPRIT LESION OF THE MID LAD. THE PATIENT UNDERWENT SES IMPLANTATION (CYPHER: 3.5 MM IN DIAMETER, 23 MM IN LENGTH) FOR THE MID LAD. IVUS AFTER SES IMPLANTATION REVEALED WELL-EXPANDED STENT STRUTS WITHOUT INCOMPLETE STENT APPOSITION. FOLLOW-UP CAG WAS PERFORMED 9 MONTHS AFTER SES IMPLANTATION. PERI-STENT CONTRAST STAINING (PSS) WAS OBSERVED IN THE SES. CONTROL OF HYPERTENSION WAS POOR; THEREFORE, THE PATIENTS¿ BLOOD PRESSURE WAS REDUCED MORE STRICTLY. CAG PERFORMED AT 46 MONTHS AFTER SES IMPLANTATION SHOWED CONTRAST STAINING OUTSIDE THE STENT STRUTS WAS MORE MARKED AND MET THE CLASSIC DEFINITION OF CAA. IVUS AND OPTICAL COHERENCE TOMOGRAPHY (OCT) REVEALED INCOMPLETE STENT APPOSITION AND STENT FRACTURE AT THE CAA. HOWEVER, IN THE BMS, AN OCT EXAMINATION REVEALED COMPLETE STENT APPOSITION. NON-OBSTRUCTIVE CORONARY ANGIOSCOPY (CAS) REVEALED THE FRACTURED EDGE OF THE SES AT THE CAA. THE FRACTURE HAD OCCURRED IN A JOINT OF THE SES. THE STENT STRUT WAS FULLY VISIBLE AND NOT COVERED BY NEOINTIMA (GRADE 0 NEOINTIMAL COVERAGE). IN CONTRAST, COMPLETE NEOINTIMAL COVERAGE WAS OBSERVED IN THE BMS SITE AND PROXIMAL EDGE OF THE SES SITE (GRADE 2 NEOINTIMAL COVERAGE). NO THROMBUS WAS DETECTED IN THE SES. WHEN WE PERFORMED CAG AT 81 MONTHS AFTER SES IMPLANTATION, THE CAA HAD EXPANDED TO MORE THAN TWICE THE SIZE OF THE REFERENCE VESSEL DIAMETER. THE PATIENT THEREFORE UNDERWENT BMS IMPLANTATION (3.5 MM IN DIAMETER, 26 MM IN LENGTH) TO COVER THE CAA. FORTUNATELY, THE FLOW OF THE LARGE DIAGONAL BRANCH WAS MAINTAINED AFTER STENTING. FOLLOW-UP CAG WAS PERFORMED AT 91 MONTHS AFTER SES IMPLANTATION (10 MONTHS AFTER THE USE OF BMS TO TREAT CAA). REGRESSION OF THE ANEURYSM WAS OBSERVED. OCT REVEALED VESSEL WALL DILATATION AND MALAPPOSED STENT STRUTS. HOWEVER, THE SIZE OF THE CAA HAD DIMINISHED, AND A VERY THIN LAYER OF ENDOTHELIUM WAS VISIBLE ON THE STRUTS. THE PATIENT CONTINUED TAKING 100 MG/DAY OF ASPIRIN AND 75 MG/DAY OF CLOPIDOGREL. THE PATIENT WAS FREE FROM CARDIAC EVENTS THROUGHOUT THE FOLLOW-UP PERIOD. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿IN-STENT CORONARY ARTERY RESTENOSIS¿ AND THE REPORTED ¿EFFORT ANGINA¿ COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. ANGINA PECTORIS AND/OR CHEST PAIN ARE SYMPTOMS OF CARDIAC ISCHEMIA GENERALLY RELATED TO A CORONARY ARTERY VESSEL OBSTRUCTION AND/OR VASOSPASM. SUBSEQUENTLY HERE IS A POTENTIAL LINK BETWEEN THE REPORTED ¿IN-STENT CORONARY ARTERY RESTENOSIS¿ AND THE REPORTED ¿EFFORT ANGINA¿. AS NO LOT NUMBER, CATALOGUE CODE OR OTHER PRODUCT INFORMATION WAS SUPPLIED A PHR COULD NOT BE COMPLETED. THE INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

Description of Event or Problem · 1

AS REPORTED IN THE LITERATURE PUBLICATION BY HADA ET AL EFFECTIVENESS OF BARE METAL STENT IMPLANTATION FOR THE TREATMENT OF CORONARY ARTERY ANEURYSM: A MULTIMODALITY IMAGING EVALUATION, INTERN MED. (B)(6) 2017, IN (B)(6) 2007, A (B)(6) MAN WAS ADMITTED WITH EFFORT ANGINA. THE PATIENTS¿ CORONARY RISK FACTORS WERE HYPERTENSION, DYSLIPIDEMIA, OBESITY AND SMOKING. THE PATIENT HAD UNDERGONE BARE METAL STENT (BMS) IMPLANTATION (BX VELOCITY: 3.5 IN DIAMETER, 28 MM IN LENGTH) FOR PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) 2 YEARS PREVIOUSLY. CORONARY ANGIOGRAPHY (CAG) REVEALED SEVERE STENOSIS OF THE MID LAD (FIG. 1A). INTRAVASCULAR ULTRASOUND (IVUS) REVEALED SEVERE NEGATIVE REMODELING AT THE CULPRIT LESION OF THE MID LAD. THE PATIENT UNDERWENT SES IMPLANTATION (CYPHER: 3.5 MM IN DIAMETER, 23 MM IN LENGTH) FOR THE MID LAD (FIG. 1B). IVUS AFTER SES IMPLANTATION REVEALED WELL-EXPANDED STENT STRUTS WITHOUT INCOMPLETE STENT APPOSITION. FOLLOW-UP CAG WAS PERFORMED 9 MONTHS AFTER SES IMPLANTATION. PERI-STENT CONTRAST STAINING (PSS) WAS OBSERVED IN THE SES (FIG. 1C). CONTROL OF HYPERTENSION WAS POOR; THEREFORE, THE PATIENTS¿ BLOOD PRESSURE WAS REDUCED MORE STRICTLY. CAG PERFORMED AT 46 MONTHS AFTER SES IMPLANTATION SHOWED CONTRAST STAINING OUTSIDE THE STENT STRUTS WAS MORE MARKED AND MET THE CLASSIC DEFINITION OF CAA (FIG. 1D). IVUS AND OPTICAL COHERENCE TOMOGRAPHY (OCT) REVEALED INCOMPLETE STENT APPOSITION (FIG. 2A, C) AND STENT FRACTURE AT THE CAA (FIG. 2B, D). HOWEVER, IN THE BMS, AN OCT EXAMINATION REVEALED COMPLETE STENT APPOSITION (FIG. 2E). NON-OBSTRUCTIVE CORONARY ANGIOSCOPY (CAS) REVEALED THE FRACTURED EDGE OF THE SES AT THE CAA (FIG. 3A, B). THE FRACTURE HAD OCCURRED IN A JOINT OF THE SES. THE STENT STRUT WAS FULLY VISIBLE AND NOT COVERED BY NEOINTIMA (GRADE 0 NEOINTIMAL COVERAGE). IN CONTRAST, COMPLETE NEOINTIMAL COVERAGE WAS OBSERVED IN THE BMS SITE AND PROXIMAL EDGE OF THE SES SITE (GRADE 2 NEOINTIMAL COVERAGE) (FIG. 3A, B AND C). NO THROMBUS WAS DETECTED IN THE SES. WHEN WE PERFORMED CAG AT 81 MONTHS AFTER SES IMPLANTATION, THE CAA HAD EXPANDED TO MORE THAN TWICE THE SIZE OF THE REFERENCE VESSEL DIAMETER (FIG. 4A). THE PATIENT THEREFORE UNDERWENT BMS IMPLANTATION (3.5 MM IN DIAMETER, 26 MM IN LENGTH) TO COVER THE CAA. FORTUNATELY, THE FLOW OF THE LARGE DIAGONAL BRANCH WAS MAINTAINED AFTER STENTING. FOLLOW-UP CAG WAS PERFORMED AT 91 MONTHS AFTER SES IMPLANTATION (10 MONTHS AFTER THE USE OF BMS TO TREAT CAA). REGRESSION OF THE ANEURYSM WAS OBSERVED (FIG. 4B). OCT REVEALED VESSEL WALL DILATATION AND MALAPPOSED STENT STRUTS (FIG. 5A, C). HOWEVER, THE SIZE OF THE CAA HAD DIMINISHED, AND A VERY THIN LAYER OF ENDOTHELIUM WAS VISIBLE ON THE STRUTS (FIG. 5B, C). THE PATIENT CONTINUED TAKING 100 MG/DAY OF ASPIRIN AND 75 MG/DAY OF CLOPIDOGREL. THE PATIENT WAS FREE FROM CARDIAC EVENTS THROUGHOUT THE FOLLOW-UP PERIOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
856212	UNKNOWN BX VELOCITY OUS	STENT, CORONARY	MAF	CORDIS CASHEL	VRXXXXX	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening