MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problems Structural Problem (2506); Device Tipped Over (2589); Appropriate Term/Code Not Available (3191)

Patient Problems Internal Organ Perforation (1987); Perforation of Vessels (2135); Ambulation Difficulties (2544); Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Procode: dtk filter, intravascular, cardiovascular.Occupation: non-healthcare professional.Investigation: it has not been possible to further investigate or evaluate this alleged event based on the limited information and/or no device failure provided to date.Catalog number and lot number are unknown, however, the alleged celect is manufactured and inspected according to specifications.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

It is alleged that the patient received a celect inferior vena cava (ivc) filter on (b)(6) 2010, and the patient was injured without further explanation.Hospital and medical records have been requested, but not yet provided.

Manufacturer Narrative

Additional information: investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.The following allegations have been investigated: organ/vena cava (vc) perforation, embedment, tilt, physical limitations.Filter interacts with ivc wall, e.G.Penetration/perforation/embedment.This may be either symptomatic or asymptomatic.Potential causes may include improper deployment; and (or) excessive force or manipulations near an in-situ filter (e.G., a surgical or endovascular procedure in the vicinity of a filter).Potential adverse events that may occur include, but are not limited to, the following: trauma to adjacent structures, vascular trauma.Filter tilt has been reported.Potential causes may include filter placement in ivcs with diameters larger than those specified in these instructions for use; improper deployment; manipulations near an implanted filter (e.G., a surgical or endovascular procedure in the vicinity of a filter); and (or) a failed retrieval attempt.Excessive filter tilt may contribute to difficult or failed retrieval; vena cava wall penetration/perforation; and (or) result in loss of filter efficiency.Potential adverse events that may occur include, but are not limited to, the following: unacceptable filter tilt.Unknown if the reported physical limitations are directly related to the filter and unable to identify a corresponding failure mode at this point in time.The catalog # and lot # are unknown, but the filter is manufactured and inspected according to specifications.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information becomes available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, or that any cook device caused or contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Patient allegedly received an implant on (b)(6) 2010 via the right common femoral vein due to bilateral deep vein thrombosis (dvt).Patient is alleging tilt, vena cava/organ perforation, and embedment.The patient further alleges "impinging on overlying bowel, and impinges upon artery and aorta," as well as physical limitations including problems walking.Medical opinion: "the filter is a cook retrievable ivc filter with the retrieval hook directed cephalad.It appears to be a gunther-tulip ivcf based on the webbing present between the upper portions of the primary anchoring struts.The filter is positioned infrarenal at the l2-3 level and is tilted anteriorly.The filter apex contacts, and is likely embedded in, the caval wall just below the renal vein confluence.All 4 primary anchoring struts perforate the ivc wall.The anterior struts impinge directly on overlying bowel, the posteromedial strut lies in very close proximity to adjacent aorta and the posterolateral strut impinges directly on the left lumbar artery at the l3 level.Filter struts appear intact.No percival thrombus or hematoma.No embolized filter fragments are identified on the imaging provided.No caval thrombosis, clot within the filter or caval wall thickening." medical opinion: "the patient¿s ivc filter is a cook celect retrievable ivc filter positioned in the patient¿s infrarenal ivc at the l2-3 level.The patient¿s ivc measures 20 mm in maximum diameter at the level of the filter.The filter is tilted anteriorly (18 degrees), such that the filter apex and hook are in direct contact with, and likely embedded in, the caval anterior wall just below l renal vein.All four (4) of the filter¿s legs (primary struts) perforate the wall of the ivc by a distance of 3 mm or greater.The perforating anterolateral and anteromedial struts impinge on the posterior wall of overlying small bowel.The perforating posteromedial strut lies in very close proximity to the posterior wall of adjacent aorta.The perforating posterolateral strut impinges directly on the right l3 lumbar artery as it passes by the lateral aspect of the l3 vertebral body.No strut fractures or missing filter components are identified.No percival hemorrhage, caval thrombosis, clot within the filter, caval wall thickening or caval stenosis is apparent on the 2019 studies.".

• Brand Name: UNKNOWN
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 15348416
• MDR Text Key: 299185068
• Report Number: 3002808486-2022-00932
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Female
• Patient Weight: 78 KG