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

Model Number FJ.120096

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2020

Event Type  Injury  

Event Description

In (b)(6) 2020, the patient underwent an ivc filter implantation procedure for dvt.On (b)(6) 2020, endoscopic images revealed perforation in the duodenum.Patient asymptomatic.On (b)(6) 2020, the physician removed the filter with the filter extraction kit.A check angiography revealed the extravasation occurred where the filter perforated.The physician thinks that it is not serious.

• Brand Name: ALN OPTIONAL VENA CAVA FILTER
• Type of Device: VENA CAVE 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: 10618675
• MDR Text Key: 209558531
• Report Number: 3007080617-2020-00003
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2020

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?: No
• Device Operator: No Information
• Device Expiration Date: 11/01/2022
• Device Model Number: FJ.120096
• Device Lot Number: 121217
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR