UNKNOWN
Report
- Report Number
- 1820334-2019-00445
- Event Type
- Injury
- Date Received
- February 19, 2019
- Report Date
- April 2, 2019
- Manufacturer
- COOK INC
- Product Code
- DTK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE IFU FOR THIS DEVICE ADDRESSES POTENTIAL ADVERSE EVENTS THAT MAY OCCUR, INCLUDING PERFORATION OF THE VENA CAVA WALL. FURTHERMORE, REVIEWS OF THE MANUFACTURES INSTRUCTIONS, DRAWINGS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT THIS EVENT IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. REVIEW OF THE LITERATURE, "DUODENAL PERFORATION WITH AN INFERIOR VENA CAVA FILTER: AN UNUSUAL CAUSE OF ABDOMINAL PAIN" BY FEEZOR, ET AL, WAS PERFORMED ON (B)(6) 2019 AND PROVIDED ADDITIONAL INFORMATION TO THE EVENT DESCRIBED IN THE INITIAL MEDWATCH REPORT. IT WAS REPORTED IN THIS LITERATURE THAT THE PATIENT WITH A HISTORY OF A PREVIOUSLY PLACED BIRDS NEST FILTER PRESENTED WITH A FOUR MONTH HISTORY OF PROGRESSIVE MID-EPIGASTRIC AND RIGHT UPPER QUADRANT PAIN, NAUSEA, ANOREXIA, INTERMITTENT CONSTIPATION, AND FORTY POUND WEIGHT LOSS. THE ABDOMINAL PAIN WAS MADE WORSE BY EATING AND WAS UNABLE TO BE RELIEVED WITH OVER-THE-COUNTER ANTACID OR PROTON PUMP INHIBITOR MEDICATIONS. VARIOUS LABORATORY AND DIAGNOSTIC PROCEDURES WERE PERFORMED. EVALUATION OF A MASS FOUND DURING THE ENDOSCOPY REVEALED A METALLIC FOREIGN BODY THAT WAS CONTAINED IN OVERLYING INFLAMMATORY TISSUE, CONSISTENT WITH A STRUT FROM THE FILTER. VENOGRAPHY REVEALED A PATENT IVC FILTER WITH FILLING DEFECTS CONSISTENT WITH A PERSISTENT CLOT. THE PATIENT WAS TRANSITIONED FROM WARFARIN TO HEPARIN AND WAS TAKEN TO SURGERY FOR EXPLORATION OF THE ABDOMEN. THE POSTERIOR MEDIAL SURFACE OF THE DUODENUM WAS DENSELY ADHERED TO THE ANTERIOR LATERAL SURFACE OF THE INFERIOR VENA CAVA (IVC), WITH MODERATE INFLAMMATION OF THE SURROUNDING TISSUES. THE ADHESION WAS DISSECTED, AND THE IVC FILTER STRUT WAS FOUND TO HAVE PERFORATED THE IVC INTO THE DUODENUM. THE STRUT WAS REMOVED FROM THE DUODENAL LUMEN AND TRIMMED FLUSH WITH THE IVC. HEMOSTASIS WAS OBTAINED. THE AREA OF DUODENAL PERFORATION WAS REPAIRED. FURTHER EXPLORATION FOUND A SECOND STRUT PERFORATION THROUGH THE IVC WALL. THE STRUT WAS LYING IMMEDIATELY POSTERIOR TO THE AORTA. THIS STRUT WAS ALSO TRIMMED FLUSH WITH THE IVC WALL. THE DEVICE WAS PALPABLY FIXED INTO PLACE. A SMALL PORTION OF OMENTUM WAS PLACED BETWEEN THE DUODENUM, IVC, AND AORTA. AFTER SURGERY, WARFARIN WAS RESUMED DUE TO THE PRESENCE OF THROMBUS FOUND ON VENOGRAPHY. IN THE THREE MONTHS AFTER SURGERY, THE PATIENT REMAINED FREE OF SYMPTOMS AND REGAINED THE WEIGHT THAT WAS PREVIOUSLY LOST. PATIENT CODE: NO CODE AVAILABLE (3191) FOR SURGICAL INTERVENTION. REPORT SOURCE: COUNTRY OF OCCURRENCE = UNITED STATES CITATION: FREEZOR, R.J., HUBER, T.S., WELBORN, M.B., & SCHELL, S.R. (2002). DUODENAL PERFORATION WITH AN INFERIOR VENA CAVA FILTER: AN UNUSUAL CAUSE OF ABDOMINAL PAIN. JOURNAL OF VASCULAR SURGERY DOI:(B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
BRAND NAME: UNKNOWN GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER. OCCUPATION: UNKNOWN. PMA/510(K) NUMBER: K161218. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
A REVIEW OF THE LITERATURE PUBLISHED IN PHLEBOLOGY IN 2018 REPORTS DUODENAL PERFORATION RESULTING FROM A BIRD'S NEST FILTER. THE (B)(6) MALE PATIENT PRESENTED WITH EPIGASTRIC PAIN (RIGHT UPPER QUADRANT) AND WEIGHT LOSS AFTER FILTER PLACEMENT FOR DEEP VEIN THROMBOSIS (DVT) AND STROKE. IT IS UNKNOWN HOW LONG THE FILTER WAS IN PLACE. IT IS UNKNOWN HOW THE DEVICE WAS RETRIEVED OR HOW THE PATIENT WAS TREATED FOR THE PERFORATION. CITATION: BAPTISTA SINCOS ET AL., (2018). SYMPTOMATIC DUODENAL PERFORATION BY INFERIOR VENA CAVA FILTER. PHLEBOLOGY, 33(8), PP523-533.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144839 | UNKNOWN | DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR | DTK | COOK INC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Life Threatening| R |