MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM; VENA CAVA FILTER

Model Number DL900F

Device Problems Occlusion Within Device (1423); Difficult to Remove (1528); Obstruction of Flow (2423)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged retrieval difficulties and occluded filter as no objective evidence has been provided to confirm any alleged deficiency with the filter.Per the provided event details, the filter was noted to be occluded at the time of the attempted retrieval.Per the ifu, "do not attempt to remove the denali filter if significant amount of thrombus are trapped within the filter or if the filter snare hook is embedded within the vena cava wall." therefore, the occlusion within the filter most likely contributed to the retrieval difficulties resulting in the filter remaining implanted.However, the definitive root cause unknown.Labeling review: the current ifu (instructions for use) states: warning: do not attempt to remove the denali filter if significant amount of thrombus are trapped within the filter or if the filter snare hook is embedded within the vena cava wall.Possible complications: caval thrombosis/occlusion.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported through the litigation process that some time post filter deployment the filter was occluded with extensive collateralization of the infrarenal ivc.An attempt to retrieve the filter was unsuccessful.The status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately six months post filter deployment, filter retrieval attempt was made.Multiple attempts were made to advance the sheath, glide wire, cobra catheter beyond the level of filter but were all unsuccessful.A pigtail flush catheter was advanced to the level of the ivc filter retrieval hook and an inferior venacavogram was performed demonstrating occlusion of the inferior vena cava at the level of the ivc filter.Hence, at this point retrieval of filter was deemed impossible and the procedure was aborted.Therefore, the investigation is confirmed for retrieval difficulties and occlusion of the ivc filter.Per the provided event details, the filter was noted to be occluded at the time of the attempted retrieval.Per the ifu, "do not attempt to remove the denali filter if significant amount of thrombus are trapped within the filter or if the filter snare hook is embedded within the vena cava wall." therefore, the occlusion within the filter most likely contributed to the retrieval difficulties resulting in the filter remaining implanted.However, the definitive root cause unknown.Labeling review: instructions for use: contraindications for use: do not attempt to remove the denali® filter if significant amounts of thrombus are trapped within the filter or if the filter snare hook is embedded within the cava wall.A review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.(expiry date: 06/2018).

Event Description

It was reported through the litigation process that some time post filter deployment the filter was occluded with extensive collateralization of the infra renal ivc.An attempt to retrieve the filter was unsuccessful.The status of the patient is unknown.New information: it was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and contraindication to anticoagulation.At some time, post filter deployment, it was alleged that the device was unable to retrieved.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately six months post filter implantation, the bard denali inferior vena cava filter was attempted for removal.The right internal jugular vein was accessed, and a 10-french sheath was placed.Then, an angled glide wire was advanced into the infrarenal inferior vena cava and multiple attempts were made to pass a glide wire beyond the level of the filter in inferior vena cava without success.A catheter was also advanced to the level of the inferior vena cava filter retrieval hook and a, inferior vena cavogram was performed which demonstrated occlusion of the inferior vena cava at the level of the inferior vena cava filter with the previously demonstrated enlarged right gonadal vein as well as a markedly enlarged left renal vein.At this point, retrieval of the filter was deemed impossible, and procedure was aborted.Therefore, the investigation is confirmed for retrieval difficulties and occlusion of the ivc filter.Per the provided event details, the filter was noted to be occluded at the time of the attempted retrieval.Therefore, the occlusion within the filter most likely contributed to the retrieval difficulties resulting in the filter remaining implanted.However, the definitive root cause unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: b6,b7,d4(expiry date: 06/2018).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism and contraindication to anticoagulation.At some time, post filter deployment, it was alleged that the filter was occluded with extensive collateralization of the infrarenal.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

• Brand Name: DENALI FEMORAL SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7304490
• MDR Text Key: 101488006
• Report Number: 2020394-2018-00170
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFZE3687
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2022
• 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
• Treatment: CIALIS; MELATONIN, B-COMPLEX, VITAMIN D3; NAPROXEN, TESTOSTERONE, ENALAPRIL, TESTIM
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: White