ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM
Report
- Report Number
- 2183460-2011-00005
- Event Type
- Other
- Date Received
- June 22, 2011
- Date of Event
- April 15, 2011
- Report Date
- June 22, 2011
- Manufacturer
- MEDRAD INTERVENTIONAL / POSSIS
- Product Code
- DXE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
EVENT CONSISTS OF PT REQUIRING BLOOD TRANSFUSIONS AND DIALYSIS TO TREAT ACUTE RENAL FAILURE POST ANGIOJET THERAPY. NOTE: FOR INTERNAL RECORD KEEPING PURPOSES THE BLOOD TRANSFUSION ADVERSE EVENT IS LISTED IN (B)(4) AND THE RENAL FAILURE ADVERSE EVENT IS LISTED IN (B)(4). HOWEVER, BOTH EVENTS OCCURRED ON THE SAME PT AND ARE BOTH RELATED TO THE INTERVENTION PROCEDURE WHICH INCLUDED ANGIOJET THERAPY. FOR THIS PURPOSE THEY ARE COMBINED INTO THIS ONE SUMMARY. THE PT IS A (B)(6) FEMALE WITH A MEDICAL HISTORY OF DIABETES, RENAL INSUFFICIENCY (STAGE 3 KIDNEY DISEASE), PERIPHERAL ARTERY DISEASE (PAD), HYPERTENSION, RECURRENT UPPER GI BLEED, AND ARRHYTHMIA. THE PT ALSO HAD A KNOWN OCCLUSION OF THE LEFT RENAL ARTERY WITH A UNILATERAL FUNCTIONING RIGHT KIDNEY. PRE-PROCEDURAL LABS INCLUDE CREATININE=1.44 MG/DL, BLOOD UREA NITROGEN (BUN)=20 MG/DL, ION POTASSIUM (K+)=3.3 MEQ/L, HEMOGLOBIN (HGB)=12.4 G/DL, PLATELETS (PLTS)=121, INR=1.1 AND PROTHROMBIN TIME (PTT)=35 SECONDS. INTERVENTION WAS PERFORMED ON (B)(6) 2011. INTERVENTION INCLUDED ANGIOJET THERAPY X6 WITH ANGIOJET XVG AND XPEEDIOR DEVICES FOR A TOTAL RUN TIME OF 37.88 MINS. IN ADDITION, THE INTERVENTION INCLUDED MANUAL ASPIRATION X3, LASER X1, AND ARTERECTOMY X2. THE PT REC'D 540 MLS OF CONTRAST DURING THE 4 PLUS HR PROCEDURE. POST PROCEDURAL HGB ON (B)(6) 2011, WAS 8.4 G/DL. THE PT WAS TRANSFUSED WITH 6 UNITS OF PACKED RED BLOOD CELLS (RBCS) OVER A 5 DAY PERIOD. ON (B)(6) 2011, THE PTS SERUM CREATININE INCREASED TO 2.7 MG/DL. THE MEDICAL RECORDS STATED THAT THERE WAS DIFFUSED PERIPHERAL EDEMA WITH NO UREMIA PRESENT. ATTEMPTS TO DIURESE WERE UNSUCCESSFUL. HEMODIALYSIS WAS PERFORMED FOR 1 WEEK WITH IMPROVEMENT AND RENAL FUNCTION RETURNING TO BASELINE PRIOR TO DISCHARGE. THE MEDICAL RECORDS STATE THAT THE RENAL FAILURE WAS "FELT TO BE THE CONTRAST NEPHROPATHY". ON (B)(6) 2011, THE PTS LABS WERE: HGB=9.4 G/DL AND PLT=154. THE PHYSICIAN DOCUMENTED THE BLOOD TRANSFUSION EVENT TO BE RELATED TO THE PROCEDURE, UNK RELATIONSHIP TO ANGIOJET THERAPY AND DRUGS. THE PHYSICIAN ALSO DOCUMENTED THE RENAL FAILURE EVENT TO BE RELATED TO THE PROCEDURE, UNK RELATIONSHIP TO ANGIOJET THERAPY, AND NO RELATIONSHIP TO DRUGS. THE NOTED TOTAL ANGIOJET RUN TIME OF 37.88 MINS WAS EXCESSIVE BASED ON THE IFU RECOMMENDATIONS OF NOT EXCEEDING 5 MINS IN A FLOWING BLOOD FIELD AND 10 MINS TOTAL. IN ADDITION, THE DOCUMENTATION SHOWS THE PT WAS HYDRATED DURING THE PROCEDURE BUT THE AMOUNT IS NOT KNOWN. THE ANGIOJET F/U WARNS: "LARGE THROMBUS BURDENS IN PERIPHERAL VEINS AND OTHER VESSELS MAY RESULT IN SIGNIFICANT HEMOGLOBINEMIA WHICH SHOULD BE MONITORED FOR POSSIBLE RENAL, PANCREATIC OR OTHER ADVERSE EVENTS." "OPERATION OF THE ANGIOJET SYSTEM CAUSES TRANSIENT HEMOLYSIS WHICH MAY MANIFEST AS HEMOGLOBINURIA. IT IS RECOMMENDED THAT THE CATHETER OPERATION NOT EXCEED 5 MINS IN A FLOWING BLOOD FIELD AND 10 MINS TOTAL. EVALUATE THE PT'S RISK TOLERANCE FOR HEMOGLOBINEMIA PRIOR TO THE PROCEDURE. CONSIDER HYDRATION PRIOR TO, DURING, AND AFTER THE PROCEDURE AS APPROPRIATE TO THE PTS OVERALL MEDICAL CONDITION." THE PT'S MEDICAL HISTORY, SUCH AS STAGE 3 KIDNEY DISEASE AND RECURRENT UPPER GI BLEED, COMBINED WITH THE VARIOUS INTERVENTIONAL PROCEDURES TO TREAT THE PT AS WELL AS THE LARGE CONTRAST AMOUNT OF 540 MLS MAY HAVE CONTRIBUTED TO THE PT REQUIRING BLOOD TRANSFUSIONS AND HEMODIALYSIS TREATMENT FOR ACUTE RENAL FAILURE POST PROCEDURE. HOWEVER, BASED ON THE INFO AVAILABLE, THE CAUSE OF CONTRIBUTING FACTOR TO THE PT'S ADVERSE EVENTS RELATED TO ANGIOJET TREATMENT CANNOT BE CONCLUSIVELY RULED OUT AND THUS THIS EVENT IS CONSIDERED REPORTABLE.
PEARL II: PT #(B)(6) ADVERSE #1 (BLEEDING REQUIRING TRANSFUSION) AND ADVERSE #2 (RENAL FAILURE): A (B)(6) FEMALE WAS ADMITTED ON (B)(6) 2011, FOR AN OCCLUDED RIGHT BRACHIAL ARTERY. MEDICAL HISTORY INCLUDES DIABETES, RENAL INSUFFICIENCY (STAGE 3 KIDNEY DISEASE), PAD, HYPERTENSION, RECURRENT UPPER GI BLEED AND ARRHYTHMIA. DOCUMENTATION ALSO STATED THAT THE PT HAD A KNOWN OCCLUSION OF THE LEFT RENAL ARTERY WITH A UNILATERAL FUNCTIONING RIGHT KIDNEY. PRE-PROCEDURAL LABS INCLUDE CREATININE=1.44 MG/DL, BUN=20 MG/DL, K+=3.3 MEQ/L, HGB=12.4 G/DL, PLTS=121, INR=1.1 AND PTT 35 SEC. INTERVENTION WAS PERFORMED ON (B)(6) 2011. INTERVENTION INCLUDED ANGIOJET X6 FOR A TOTAL RUN TIME OF 37.88 MINS. IN ADDITION, THE INTERVENTION INCLUDED MANUAL ASPIRATION X3, LASER X1 AND ATHERECTOMY X2. THE PT REC'D 540 ML OF CONTRAST DURING THE 4+ HR PROCEDURE. AE #1: ON (B)(6) 2011, PT'S HGB=8.4 G/DL AND PT WAS TRANSFUSED 6 UNITS OF PACKED RBCS (OVER A 5 DAY PERIOD). ON (B)(6) 2011, PT'S LABS WERE HGB=9.4 G/DL, PLT=154. PHYSICIAN DOCUMENTED THE EVENT CAUSALITY AS: EVENT RELATED TO THE PROCEDURE: YES. EVENT RELATED TO THE ANGIOJET: UNK. EVENT RELATED TO A DRUG: UNK. AE#2: ON (B)(6) 2011, OF THE SAME ADMISSION, THE PT'S SERUM CREATININE INCREASED TO 2.7 MG/DL. DOCUMENTATION STATED THAT THERE WAS DIFFUSE PERIPHERAL EDEMA WITH NO UREMIA PRESENT. ATTEMPTS TO DIURESE WERE UNSUCCESSFUL. HEMODIALYSIS WAS PERFORMED FOR 1 WEEK WITH IMPROVEMENT AND RENAL FUNCTION RETURNING TO BASELINE PRIOR TO DISCHARGE. MEDICAL RECORD STATES THAT THE RENAL FAILURE WAS "FELT TO BE THE CONTRAST NEPHROPATHY". PHYSICIAN DOCUMENTED THE EVENT CAUSALITY AS: EVENT RELATED TO THE PROCEDURE: YES. EVENT RELATED TO THE ANGIOJET: UNK. EVENT RELATED TO A DRUG: NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM | AJ SYSTEM | DXE | MEDRAD INTERVENTIONAL / POSSIS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |