MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number UNK140

Device Problems Fracture (1260); Device Or Device Fragments Location Unknown (2590)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the complaint device was not returned for analysis.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).

Event Description

It was reported that a filter fracture occurred.The patient had a greenfield filter implanted on (b)(6) 1998.The filter is now fractured and imbedded into the patient's vein.The filter cannot be removed.It is unknown where the fractured portion is.The patient has pain on her left side and has extremely high blood pressure.Bsc is continuing to follow up for additional information.

• Brand Name: STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7310542
• MDR Text Key: 101411041
• Report Number: 2134265-2018-01346
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 48 YR