EXPRESS LD VASCULAR

Report

Report Number: 2124215-2025-42441
Event Type: Injury
Date Received: June 26, 2025
Date of Event: February 20, 2024
Report Date: July 28, 2025
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: FGE
UDI-DI: 08714729485117
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

B3: DATE OF EVENT ESTIMATED USING DATE LITERATURE ARTICLE WAS RECEIVED FOR PUBLICATION. D6A: IMPLANT DATE ESTIMATED USING DATE LITERATURE ARTICLE WAS RECEIVED FOR PUBLICATION. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BOSTON SCIENTIFIC AS THIS WAS REPORTED THROUGH A LITERATURE ARTICLE. IZAWA, DAISUKE & MATSUMOTO, HIROYUKI & NAKANISHI, YUTA & SHIMIZU, TOSHIKI & NISHIYAMA, HIROKAZU. (2024). ASYMPTOMATIC COMPLETE SPIRAL STENT FRACTURE IN SUBCLAVIAN ARTERY WITH PROGRESSIVE RESTENOSIS IN THE EARLY POSTOPERATIVE PERIOD: A CASE REPORT. JOURNAL OF NEUROENDOVASCULAR THERAPY. 18. DOI: 10.5797/JNET.CR.2024-0019.

Additional Manufacturer Narrative · 0

B3: DATE OF EVENT ESTIMATED USING DATE LITERATURE ARTICLE WAS RECEIVED FOR PUBLICATION. D6A: IMPLANT DATE ESTIMATED USING DATE LITERATURE ARTICLE WAS RECEIVED FOR PUBLICATION. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BOSTON SCIENTIFIC AS THIS WAS REPORTED THROUGH A LITERATURE ARTICLE. IZAWA, DAISUKE & MATSUMOTO, HIROYUKI & NAKANISHI, YUTA & SHIMIZU, TOSHIKI & NISHIYAMA, HIROKAZU. (2024). ASYMPTOMATIC COMPLETE SPIRAL STENT FRACTURE IN SUBCLAVIAN ARTERY WITH PROGRESSIVE RESTENOSIS IN THE EARLY POSTOPERATIVE PERIOD: A CASE REPORT. JOURNAL OF NEUROENDOVASCULAR THERAPY. 18. DOI: 10.5797/JNET.CR.2024-0019.

Description of Event or Problem · 0

IT WAS REPORTED VIA LITERATURE THAT STENT FRACTURE AND IN-STENT RESTENOSIS OCCURRED. THE PATIENT PRESENTED WITH A 2-MONTH HISTORY OF LEFT ARM UPPER LIMB CLAUDICATION. MAGNETIC RESONANCE IMAGING AT THE TIME OF ADMISSION SHOWED SEVERE STENOSIS OF THE LEFT PROXIMAL SUBCLAVIAN ARTERY (SCA) WITH SEVERE TWISTED CALCIFICATION AT THE ORIGIN OF THE SCA. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND STENTING (PTAS) USING AN EXPRESS LD BALLOON-EXPANDABLE STENT. UNDER LOCAL ANESTHESIA, A 6-FR NON-BOSTON SCIENTIFIC (BSC) GUIDE SHEATH WAS INSERTED INTO THE ORIFICE OF THE LEFT SCA AT THE RIGHT FEMORAL ARTERY APPROACH, AND A 4-FR SHEATH WAS INSERTED INTO THE LEFT BRACHIAL ARTERY. A NON-BSC SNARE WIRE WITH A 7-MM DIAMETER LOOP WAS INTRODUCED THROUGH THE LEFT BRACHIAL ARTERY INTO THE LEFT SCA. A 0.035-INCH 300-CM GUIDEWIRE WAS INSERTED AND GUIDED THROUGH THE STENOTIC LESION AND INTO THE LEFT BRACHIAL ARTERY, THEN THE TIP OF THE GUIDEWIRE WAS PASSED THROUGH THE LOOP OF THE SNARE WIRE. THE GUIDEWIRE WAS CAPTURED IN THE LEFT BRACHIAL ARTERY AND PULLED OUT OF THE LEFT BRACHIAL 4-FR SHEATH. UNDER THIS PULL-THROUGH SYSTEM, PRE-PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED; A 6 MM X 40 MM MUSTANG BALLOON WAS INFLATED AT 10 ATM PRESSURE. AN 8 MM X 27 MM EXPRESS LD BALLOON-EXPANDABLE STENT WAS DEPLOYED AT 8 ATM PRESSURE IN A POSITION WHERE IT DID NOT PROTRUDE INTO THE AORTA WITHOUT LEFT VERTEBRAL ARTERY (VA) PROTECTION. POSTOPERATIVE ANGIOGRAPHY SHOWED GOOD ANGIOGRAPHIC DILATATION, BUT THE TWISTED VESSEL WAS STRAIGHTENED AND THE LEFT VA WAS ASYMPTOMATICALLY OCCLUDED. ON POSTOPERATIVE FLUOROSCOPY, MODERATE HINGE MOTION WAS OBSERVED AT THE MID-PORTION OF THE IMPLANTED STENT WITH THE PULSATION OF THE SCA. ULTRASONOGRAPHY THE DAY AFTER TREATMENT SHOWED APPROPRIATE STENT PLACEMENT. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) 30 DAYS AFTER PTAS SHOWED AN ASYMPTOMATIC COMPLETE SPIRAL STENT FRACTURE AT THE MID-PORTION OF THE STENT. BECAUSE IT WAS AN ASYMPTOMATIC STENT FRACTURE, IT WAS FOLLOWED CONSERVATIVELY. THE IN-STENT STENOSIS THEN GRADUALLY PROGRESSED ON FOLLOW-UP ULTRASONOGRAPHY AT THE SITE OF THE STENT FRACTURE. NINE MONTHS AFTER THE FIRST PTAS, A SECOND PTAS USING A SELF-EXPANDABLE NITINOL STENT WAS PERFORMED BECAUSE THE PEAK SYSTOLIC VELOCITY EXCEEDED 300 CM/S ON DOPPLER ULTRASOUND. UNDER LOCAL ANESTHESIA, A NON-BSC 6-FR DILATOR KIT WAS INSERTED INTO THE ORIFICE OF THE LEFT SCA AT THE RIGHT FEMORAL ARTERY APPROACH, AND 5/6-FR NON-BSC SHEATH WAS INSERTED INTO THE LEFT BRACHIAL ARTERY. ON PREOPERATIVE ANGIOGRAPHY, A STENT FRACTURE WAS IDENTIFIED SLIGHTLY DISTAL TO THE PREVIOUSLY TREATED STENOSIS SITE, AND IN-STENT STENOSIS DUE TO STENT DEFORMATION AND INTIMAL HYPERPLASIA WAS OBSERVED AT THE FRACTURED PART. UNDER THE PULL-THROUGH SYSTEM AS THE FIRST TREATMENT, A NON-BSC 7 MM X 40 MM PRE-PTA BALLOON WAS INFLATED AT 10 ATM PRESSURE. A NON-BSC 10 MM X 40 MM SELF-EXPANDABLE STENT WAS DEPLOYED IN A POSITION WHERE IT DID NOT PROTRUDE INTO THE AORTA. FLUOROSCOPY THE DAY AFTER THE SECOND PTAS DID NOT SHOW STENT DEFORMATION DUE TO UPPER LIMB MOVEMENT, BUT IT SHOWED HINGE MOTION WITH SCA PULSATION. TWO YEARS AFTER THE SECOND PTAS, THERE WERE NO SYMPTOMS AND NO STENT DEFORMATION, BUT MILD INTIMAL HYPERPLASIA WAS OBSERVED AT THE SITE OF THE HINGE MOTION ON CTA.

Description of Event or Problem · 0

IT WAS REPORTED VIA LITERATURE THAT STENT FRACTURE AND IN-STENT RESTENOSIS OCCURRED. THE PATIENT PRESENTED WITH A 2-MONTH HISTORY OF LEFT ARM UPPER LIMB CLAUDICATION. MAGNETIC RESONANCE IMAGING AT THE TIME OF ADMISSION SHOWED SEVERE STENOSIS OF THE LEFT PROXIMAL SUBCLAVIAN ARTERY (SCA) WITH SEVERE TWISTED CALCIFICATION AT THE ORIGIN OF THE SCA. THE PATIENT UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND STENTING (PTAS) USING AN EXPRESS LD BALLOON-EXPANDABLE STENT. UNDER LOCAL ANESTHESIA, A 6-FR NON-BOSTON SCIENTIFIC (BSC) GUIDE SHEATH WAS INSERTED INTO THE ORIFICE OF THE LEFT SCA AT THE RIGHT FEMORAL ARTERY APPROACH, AND A 4-FR SHEATH WAS INSERTED INTO THE LEFT BRACHIAL ARTERY. A NON-BSC SNARE WIRE WITH A 7-MM DIAMETER LOOP WAS INTRODUCED THROUGH THE LEFT BRACHIAL ARTERY INTO THE LEFT SCA. A 0.035-INCH 300-CM GUIDEWIRE WAS INSERTED AND GUIDED THROUGH THE STENOTIC LESION AND INTO THE LEFT BRACHIAL ARTERY, THEN THE TIP OF THE GUIDEWIRE WAS PASSED THROUGH THE LOOP OF THE SNARE WIRE. THE GUIDEWIRE WAS CAPTURED IN THE LEFT BRACHIAL ARTERY AND PULLED OUT OF THE LEFT BRACHIAL 4-FR SHEATH. UNDER THIS PULL-THROUGH SYSTEM, PRE-PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED; A 6 MM X 40 MM MUSTANG BALLOON WAS INFLATED AT 10 ATM PRESSURE. AN 8 MM X 27 MM EXPRESS LD BALLOON-EXPANDABLE STENT WAS DEPLOYED AT 8 ATM PRESSURE IN A POSITION WHERE IT DID NOT PROTRUDE INTO THE AORTA WITHOUT LEFT VERTEBRAL ARTERY (VA) PROTECTION. POSTOPERATIVE ANGIOGRAPHY SHOWED GOOD ANGIOGRAPHIC DILATATION, BUT THE TWISTED VESSEL WAS STRAIGHTENED AND THE LEFT VA WAS ASYMPTOMATICALLY OCCLUDED. ON POSTOPERATIVE FLUOROSCOPY, MODERATE HINGE MOTION WAS OBSERVED AT THE MID-PORTION OF THE IMPLANTED STENT WITH THE PULSATION OF THE SCA. ULTRASONOGRAPHY THE DAY AFTER TREATMENT SHOWED APPROPRIATE STENT PLACEMENT. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) 30 DAYS AFTER PTAS SHOWED AN ASYMPTOMATIC COMPLETE SPIRAL STENT FRACTURE AT THE MID-PORTION OF THE STENT. BECAUSE IT WAS AN ASYMPTOMATIC STENT FRACTURE, IT WAS FOLLOWED CONSERVATIVELY. THE IN-STENT STENOSIS THEN GRADUALLY PROGRESSED ON FOLLOW-UP ULTRASONOGRAPHY AT THE SITE OF THE STENT FRACTURE. NINE MONTHS AFTER THE FIRST PTAS, A SECOND PTAS USING A SELF-EXPANDABLE NITINOL STENT WAS PERFORMED BECAUSE THE PEAK SYSTOLIC VELOCITY EXCEEDED 300 CM/S ON DOPPLER ULTRASOUND. UNDER LOCAL ANESTHESIA, A NON-BSC 6-FR DILATOR KIT WAS INSERTED INTO THE ORIFICE OF THE LEFT SCA AT THE RIGHT FEMORAL ARTERY APPROACH, AND 5/6-FR NON-BSC SHEATH WAS INSERTED INTO THE LEFT BRACHIAL ARTERY. ON PREOPERATIVE ANGIOGRAPHY, A STENT FRACTURE WAS IDENTIFIED SLIGHTLY DISTAL TO THE PREVIOUSLY TREATED STENOSIS SITE, AND IN-STENT STENOSIS DUE TO STENT DEFORMATION AND INTIMAL HYPERPLASIA WAS OBSERVED AT THE FRACTURED PART. UNDER THE PULL-THROUGH SYSTEM AS THE FIRST TREATMENT, A NON-BSC 7 MM X 40 MM PRE-PTA BALLOON WAS INFLATED AT 10 ATM PRESSURE. A NON-BSC 10 MM X 40 MM SELF-EXPANDABLE STENT WAS DEPLOYED IN A POSITION WHERE IT DID NOT PROTRUDE INTO THE AORTA. FLUOROSCOPY THE DAY AFTER THE SECOND PTAS DID NOT SHOW STENT DEFORMATION DUE TO UPPER LIMB MOVEMENT, BUT IT SHOWED HINGE MOTION WITH SCA PULSATION. TWO YEARS AFTER THE SECOND PTAS, THERE WERE NO SYMPTOMS AND NO STENT DEFORMATION, BUT MILD INTIMAL HYPERPLASIA WAS OBSERVED AT THE SITE OF THE HINGE MOTION ON CTA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1270838	EXPRESS LD VASCULAR	CATHETER, BILIARY, DIAGNOSTIC	FGE	BOSTON SCIENTIFIC CORPORATION	20212		08714729485117

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR	Female	Required Intervention