WALLSTENT ENDOPROSTHESIS
Received Dec 1, 2025 · Event occurred Jul 29, 2025
Report 2124215-2025-84234 · MDR key 23687800
Device
Generic name
Catheter, Biliary, Diagnostic
Manufacturer
Boston Scientific CorporationModel number
H965403330Catalog number
H965403330
Lot number
0032134773
Product problems
- Adverse Event Without Identified Device or Use Problem
- Activation Failure
- Adverse Event Without Identified Device or Use Problem
- Activation Failure
Patient
63 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E1 - INITIAL REPORTER PHONE: (B)(6). G4 - PREMARKET / 510(K) #: K152842, K980163, P980033. DEVICE EVALUATED BY MFR: THE WALLSTENT ENDOPROSTHESIS DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL AND TACTILE EXAMINATION IDENTIFIED AN OUTER SHEATH KINK APPROXIMATELY 745MM PROXIMAL FROM THE DISTAL TIP, AND AN INNER SHEATH KINK APPROXIMATELY 95MM PROXIMAL FROM THE DISTAL TIP. THE STENT WAS RETURNED SHEATHED ON THE DEVICE. THE STENT WAS DEPLOYED WITH RESISTANCE EXPERIENCED DUE TO THE OUTER SHEATH KINK. THE STENT WAS FOUND TO BE DAMAGED AT THE SAME LOCATION AS THE SHEATH KINK WHEN IT WAS MOUNTED ON THE DELIVERY SYSTEM. A VISUAL EXAMINATION IDENTIFIED NO DAMAGE OR ISSUES WITH THE STENT CUPS, STENT HOLDER, OR TIP OF THE RETURNED DEVICE.
Description of Event or Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED VEIN. A 16MM X 90MM X 75CM WALLSTENT ENDOPROSTHESIS SELF-EXPANDING STENT WAS SELECTED FOR USE. DURING ATTEMPTED DEPLOYMENT, THE DELIVERY SYSTEM WOULD NOT RELEASE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A DAMAGED STENT.