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

Model Number	DL900F
Medical Device Problem Codes	Positioning Failure (1158); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Activation Failure (3270); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Medical device - expiry date: 07/2023.
Event or Problem Description
It was reported that during a filter placement procedure through the right femoral vein, the filter allegedly migrated to the heart and failed to deploy.It was further reported that the device was allegedly difficult to be removed from the body using a retrieval device.The device was reported to be removed with further intervention.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failures as no objective evidence was provided for review.A definitive root cause could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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.H3: device not returned.
Event or Problem Description
It was reported that during a filter placement procedure through the right femoral vein, the filter allegedly migrated to the heart and failed to deploy.It was further reported that the device was allegedly difficult to be removed from the body using a retrieval device.The device was reported to be removed with further intervention.The current status of the patient is unknown.
Event or Problem Description
It was reported that during a filter placement procedure through the right femoral vein, the filter allegedly migrated and embolized to the heart and failed to deploy.It was further reported that the device was allegedly difficult to be removed from the body using a retrieval device.The device was reported to be removed with further intervention.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failures as no objective evidence was provided for review.A definitive root cause for the alleged failure to expand of the filter, migration of the filter and retrieval difficulties could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 07/2023).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.H3 other text : device not returned.
Event or Problem Description
It was reported that during a filter placement procedure through the right femoral vein, the filter allegedly migrated and embolized to the heart and failed to deploy.It was further reported that the device was allegedly difficult to be removed from the body using a retrieval device.The device was reported to be removed with further intervention.The current status of the patient is unknown.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failures as no objective evidence was provided for review.A definitive root cause could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 07/2023).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.H3 other text: device not returned.

• Brand Name: DENALI FEMORAL SYSTEM
• Common Device Name: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10893432
• Report Number: 2020394-2020-20566
• Device Sequence Number: 15757037
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFEU0222
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 02/03/2021; 04/28/2021; 05/26/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 03/02/2021; 05/21/2021; 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention