MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY IVC FILTER; DEVICE, PERCUTANEOUS RETRIEVAL

Device Problem Fracture (1260)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 11/18/2021

Event Type  Injury  

Event Description

Recovery ivcf found to have one arm fractured and retain in right renal vein.Filter heavily calcified, requiring 26f sheath and forceps to remove.Fragment removed.Fda safety report id # (b)(4).

• Brand Name: RECOVERY IVC FILTER
• Type of Device: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• MDR Report Key: 12860916
• MDR Text Key: 281215813
• Report Number: MW5105507
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Hispanic
• Patient Race: White