MAUDE Adverse Event Report: ALN IMPLANTS CHIRURGICAUX ALN OPTIONAL VENA CAVA FILTER

Model Number FJ.120096

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hematoma (1884)

Event Type  Injury  

Event Description

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.

• Brand Name: ALN OPTIONAL VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): ALN IMPLANTS CHIRURGICAUX; 589 chemin du niel; bormes les mimosas, 83230 ; FR 83230
• Manufacturer Contact: severine joly ; 589 chemin du niel; bormes les mimosas, 83230 ; FR 83230
• MDR Report Key: 10981730
• MDR Text Key: 220646372
• Report Number: 3007080617-2020-00005
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 03760017680011
• UDI-Public: 3760017680011
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K163699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FJ.120096
• Device Lot Number: 110917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other