ALN Optional Vena Cava Filter - Jugular Approach FJ.120096Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03760017680011), received between Oct 2, 2020 and Jul 15, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2024Entrapment of Device; Entrapment of Device

  THE PATIENT UNDERWENT THE IVC FILTER PLACEMENT ABOUT 1.5 YEARS AGO (APPROXIMATE IMPLANTATION DATE: (B)(6) 2022). THE ATTENDING PHYSICIAN THIS TIME OBSERVED UNDER COMPUTED TOMOGRAPHY AT THE PATIENT'S 1.5-YEAR FOLLOW-UP VISIT THAT THE INFERIOR VENA CAVA WAS PERFORATED. TO BE MORE SPECIFIC, THE PHYSICIAN OBSERVED THE PERFORATION BY AND DEVIATION OF 6 LEGS OF THE FILTER. DAMAGES TO THE AORTA WERE ALSO DEEPLY CONCERNED. THE PHYSICIAN REMOVED THE FILTER SURGICALLY. THE REMOVED FILTER WAS DISPOSED OF BY THE MEDICAL INSTITUTION. PATIENT'S CONDITION AFTER THE OPERATION: FAVORABLE. THIS INFORMATION WAS OBTAINED THROUGH A POSTER PRESENTATION AT THE JAPANESE SOCIETY FOR VASCULAR SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19738299 ↗
• MalfunctionJun 2, 2022Entrapment of Device; Entrapment of Device

  ON (B)(6) 2022, THE PATIENT UNDERWENT AN IVC FILTER IMPLANTATION PROCEDURE. THE PATIENT ANATOMY WAS TORTUOUS. THE TWO LONGEST STRUTS PERFORATED THE VESSEL A LITTLE BIT, BUT WERE NOT CONSIDERED SERIOUS. ON (B)(6) 2022, THE CATHETERIST/PHYSICIAN REVIEWED THE IMAGES AND NOTED THAT TWO STRUTS HAD VESSEL PERFORATED APPROXIMATELY 2 CM. THERE WAS A SMALL AMOUNT OF HEMORRHAGE FROM THE RIGHT VESSEL WALL WHERE ONE OF THE STRUTS PERFORATED. ADDITIONAL PROCEDURE HAVE NOT BEEN TAKEN. PATIENT'S CONDITION AFTER THE OPERATION: AS OF TODAY: NO ABDOMINAL PAIN, NO DECREASE IN VITALS, NO SERIOUS ADVERSE EVENT. THE DEVICE WILL BE IMPLANTED PERMANENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14572571 ↗
• InjuryMay 5, 2022Entrapment of Device; Entrapment of Device

  ON (B)(6) 2022, THE PATIENT UNDERWENT AN IVC FILTER IMPLANTATION PROCEDURE. THE IMPLANTED FILTER TILTED AND NOT PERFORATED THE VESSEL WALL. ON AN UNKNOWN DATE OF (B)(6) 2022, THE PATIENT UNDERWENT CT SCAN FOR FILTER EXTRACTION PROCEDURE, WHICH SHOWED TWO OF THE ANCHORAGE STRUTS PERFORATED THE VESSEL WALL. ON (B)(6) 2022, THE PATIENT UNDERWENT A FILTER EXTRACTION PROCEDURE. THE FILTER WAS EXTRACTED. POSTOPERATIVE ANGIOGRAPHY DID NOT SHOW CONTRAST AGENT LEAKED FROM THE BLOOD VESSELS. PATIENT'S CONDITION FAVORABLE AFTER THE OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286470 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT AN IVC FILTER IMPLANTATION PROCEDURE FOR CENTRAL DEEP VEIN THROMBOSIS AS A PREVENTIVE TREATMENT OF OOPHORECTOMY. ON THE MORNING OF (B)(6) 2021, THE PATIENT UNDERWENT AN OOPHORECTOMY PROCEDURE. A POSTOPERATIVE X-RAY SHOWED THE FILTER MIGRATED TO THE SUPERIOR VENA CAVA. ON THE AFTERNOON OF (B)(6) 2021, THE PATIENT UNDERWENT A FILTER EXTRACTION PROCEDURE. THE FILTER WAS RETRIEVED SUCCESSFULLY. NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13590066 ↗
• InjuryMar 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  EVENT: VASCULAR INJURY. ON (B)(6) 2021, THE PATIENT UNDERWENT AN ALN FILTER IMPLANTATION IN THE INFRARENAL INFERIOR VENA CAVA TO PREVENT PULMONARY THROMBOEMBOLISM. ON (B)(6) 2021, THE PATIENT COMPLAINED OF BACK PAIN. CT WAS PERFORMED AND SHOWED THAT THE LUMBAR ARTERY NEAR THE IMPLANTED FILTER WAS DAMAGED AND BLEEDING. IT BECAME A LARGE HEMATOMA COMPRESSING THE VENA CAVA. THE PATIENT UNDERWENT AN ACUTE PROCEDURE. A CUFF OF AFX STENT GRAFT SYSTEM ((B)(6) LIFELINE) WAS PLACED IN THE AORTA TO STOP THE BLEEDING. THE PROCEDURE WAS FISHED. PATIENT'S CONDITION AFTER THE OPERATION: THE PATIENT IS NO MORE IN PAIN. THE HEMATOMA HOWEVER STILL COMPRESSES THE FILTER AND THE VENA CAVA, WHICH BECAME NARROWED AND DEFORMED. PHYSICIAN'S COMMENT: I IMPLANTED THE FILTER SUCCESSFULLY AND APPROPRIATELY IN ORDER NOT TO COMPRESS THE VESSELS, ALTHOUGH THE TARGET VEIN MIGHT HAVE BEEN SMALLER IN DIAMETER THAN I THOUGHT. IMAGES TAKEN AFTER THE IMPLANTATION SUGGESTED NO PROBLEM. I SUSPECTED THE IMPLANTED FILTER CAUSED THE PAIN BASED ON THE AREA THE PATIENT INDICATED, SO I TOOK A CT SCAN RIGHT AWAY. THE PATIENT MIGHT HAVE DIED IF I HAD NOT FOUND THE BLEEDING THEN.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 11451141 ↗
• InjuryDec 10, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2020, THE PATIENT UNDERWENT A FILTER IMPLANTATION PROCEDURE. ON (B)(6) 2020, A CT SCAN FOUND NO ABNORMALITY IN THE PATIENT. ON (B)(6) 2020, THE PATIENT COMPLAINED OF BACK PAIN. A CT SCAN REVEALED A RETROPERITONEAL HEMATOMA. WHETHER PERFORATION OCCURRED OR NOT WAS UNKNOWN BECAUSE AN ANGIOGRAPHY WAS NOT PERFORMED. THERE ARE NO EXTERNAL FACTORS FOUND WHICH MIGHT CAUSE PERFORATION, AND THE INFLUENCE OF THE TREATED TUMOR WAS UNLIKELY. ON (B)(6) 2020, IT WAS PLANNED TO TRANSFER THE PATIENT TO THE NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER. BECAUSE DR. (B)(6) OF THE INITIAL HOSPITAL COULD NOT PERFORM THE FILTER RETRIEVAL PROCEDURE DUE TO MISSING THE SURGICAL BACKUP SECTION. PATIENT'S CONDITION AFTER THE OPERATION: THE PATIENT IS TREATED WITH OBSERVATION.

  Patient problems: Hematoma

  MAUDE report 10981730 ↗
• InjuryOct 2, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IN (B)(6) 2020, THE PATIENT UNDERWENT AN IVC FILTER IMPLANTATION PROCEDURE FOR DVT. ON (B)(6) 2020, ENDOSCOPIC IMAGES REVEALED PERFORATION IN THE DUODENUM. PATIENT ASYMPTOMATIC. ON (B)(6) 2020, THE PHYSICIAN REMOVED THE FILTER WITH THE FILTER EXTRACTION KIT. A CHECK ANGIOGRAPHY REVEALED THE EXTRAVASATION OCCURRED WHERE THE FILTER PERFORATED. THE PHYSICIAN THINKS THAT IT IS NOT SERIOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10618675 ↗