ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
Report
- Report Number
- 1820334-2018-02691
- Event Type
- Injury
- Date Received
- September 10, 2018
- Report Date
- December 4, 2018
- Manufacturer
- COOK INC
- Product Code
- DQY
- PMA / PMN Number
- K091527
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION : PRODUCT IDENTIFIER (B)(6). DEVICE NAME ADVANCE 35 LP LOW PROFILE BALLOON CATHETE COMMON NAME DQY CATHETER, PERCUTANEOU PRODUCT CODE DQY. MANUFACTURER (ADDRESS) COOK INC. RPN (B)(4). THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED. - ATTACHMENT: [PR 237582_COPY OF JOURNAL ARTICLE_HV_10SEP2018.PDF]
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. D4. LOT NUMBER 5943393, EXPIRATION DATE JUN2018 INVESTIGATION ¿ EVALUATION A REVIEW OF THE DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, IMAGES WHICH WERE INCLUDED IN THE SOURCE DOCUMENT WERE ASSESSED BY A PHYSICIAN AS A PART OF THE INVESTIGATION. NO SIGNIFICANT FINDINGS RELATED TO THE USE OF THE BALLOON CATHETER WERE REPORTED. OBSERVATIONS REGARDING THE DISEASED STATE OF THE PATIENT WERE OUTLINED AND CONFIRM INDICATIONS OF ACTIVE INFLAMMATION AS EXPECTED WITH TAKAYASU¿S ARTERITIS. IN THE PHYSICIAN¿S PROFESSIONAL OPINION, THE DISEASED STATE MAY BE ATTRIBUTED TO THE VESSEL DISSECTION THAT PRESENTED AFTER BALLOON ANGIOPLASTY. THE JOURNAL ARTICLE ALSO HYPOTHESIZES THAT ¿LURKING¿ VESSEL INFLAMMATION ¿COULD HAVE CONTRIBUTED TO THE RAPID PROGRESSION OF MINOR DISSECTION IN THIS PATIENT.¿ ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. EACH DEVICE IS SHIPPED WITH AN ¿INSTRUCTIONS FOR USE¿ DOCUMENT AND COMPLIANCE CARD. THE COMPLIANCE CARD SPECIFIES THE BALLOON INFLATION VOLUME AND CORRESPONDING DIAMETERS. THE IFU INSTRUCTIONS DESCRIBE THE APPROPRIATE PREPARATION, INFLATION, DEFLATION AND WITHDRAWAL FOR THE DEVICE. IT ALSO INCLUDES THE INTENDED USE OF THE DEVICE, WHICH INCLUDES ILIAC, POPLITEAL, INFRAPOPLITEAL, RENAL, FEMORAL AND ILIOFEMORAL ARTERIES. THE IFU ALSO CONTAINS POTENTIAL ADVERSE EVENTS, INCLUDING VESSEL DISSECTION, PERFORATION, RUPTURE OR INJURY. THE NOMINAL PRESSURE FOR THIS DEVICE IS 8 ATM. THE ARTICLE REPORTED THAT THE BALLOON WAS INFLATED TO 4 ATM. BASED ON THE COMPLIANCE CARD, 9.11 MM IS THE CORRESPONDING BALLOON DIAMETER WHEN INFLATED TO 4 ATM. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, THE INVESTIGATION DETERMINED A COMBINATION OF THE DISEASED VASCULATURE, KNOWN DEVICE RISK, AND OFF-LABEL USAGE RESULTED IN THE VESSEL DISSECTION OF THE DESCENDING THORACIC AORTA AFTER BALLOON ANGIOPLASTY. THE AORTIC OCCLUSION AND PSEUDOANEURYSM WERE DETERMINED TO BE CASCADING EFFECTS FROM THE INITIAL DISSECTION THAT WAS OBSERVED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED. - ATTACHMENT: [PR 237582_COPY OF JOURNAL ARTICLE_HV_10SEP2018.PDF]
PLEASE SEE H10 FOR ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED IN SECTION H10.
COMMON NAME & PRODUCT CODE = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. CONCOMITANT PRODUCTS: BOSTON SCIENTIFIC CUTTING BALLOON. PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. CITATION: HTTP://DX.DOI.ORG/10.1016/J.IHJCCR.2017.08.003 - [(B)(4)].
A JOURNAL ARTICLE, "AORTIC OCCLUSION AFTER BALLOON ANGIOPLASTY IN INFLAMMATORY MIDDLE AORTIC SYNDROME" WAS REVIEWED WHICH REPORTED THE FOLLOWING: BALLOON ANGIOPLASTY WAS DONE SUCCESSFULLY IN A YOUNG GIRL WITH TAKAYASU¿S ARTERITIS (TA). NON-FLOW LIMITING DISSECTION WAS NOT STENTED. ON THE FOURTH DAY OF THE PROCEDURE, THE PATIENT PRESENTED WITH OBSTRUCTING DISSECTION AND PSEUDOANEURYSM. BIOMARKERS OF DISEASE ACTIVITY WERE NEGATIVE. THE AUTHORS REPORT BALLOON ANGIOPLASTY HAS EMERGED AS AN EFFECTIVE TREATMENT FOR MIDDLE AORTIC SYNDROME SECONDARY TO TAKAYASU¿S ARTERITIS (TA) WITH LOW INCIDENCE OF COMPLICATIONS. IN CHILDREN AND ADOLESCENTS, STENTING OF THE SEGMENT AFTER ANGIOPLASTY IS DONE WHEN THE DISSECTION IS EXTENSIVE. NON-FLOW LIMITING DISSECTIONS ARE USUALLY LEFT ALONE, AS STENTING IS ASSOCIATED WITH REDUCED GROWTH POTENTIAL OF THE SEGMENT. ALSO, THE NEED FOR RE-DILATION AND STENTING REQUIRES PLACEMENT OF LARGE SIZED SHEATHS. STENTING OF LOWER THORACIC SEGMENTS IS ASSOCIATED WITH RISK OF SPINAL CORD ISCHEMIA AS WELL. WE DESCRIBE A COMPLICATED BALLOON ANGIOPLASTY OF THE DESCENDING THORACIC AORTA(DTA) AND ABDOMINAL AORTA (AA) IN A (B)(6)-YEAR-OLD GIRL WITH KNOWN TA. A (B)(6)-YEAR-OLD GIRL WAS DIAGNOSED AS A CASE OF TA (TYPE V) WHEN SHE PRESENTED WITH HEART FAILURE AND HYPERTENSION ONE YEAR AGO. THE DURATION OF HER HEART FAILURE SYMPTOMS HAD BEEN FOR TWO WEEKS. SHE ALSO HAD A YEAR LONG HISTORY OF BOTH LOWER LIMB (LL) CLAUDICATION. SHE WAS FOUND TO HAVE ABSENT PULSES IN THE LEFT UPPER LIMB AND BOTH LL. BLOOD PRESSURE RECORDED IN THE RIGHT UPPER LIMB WAS 140/90 MMHG. THE 2D ECHOCARDIOGRAM REVEALED SEVERE LEFT VENTRICULAR (LV) DYSFUNCTION WITH LV DIMENSIONS BEING 56 MM (END DIASTOLE)/50 MM (END SYSTOLE), EJECTION FRACTION (EF) OF 25% ALONG WITH MILD MITRAL REGURGITATION. COMPUTED TOMOGRAPHY ANGIOGRAM(CTA) DONE ONE YEAR AGO AT THE TIME OF DIAGNOSIS, REVEALED LONG SEGMENT STENOSIS OF THE DESCENDING THORACIC AORTA (DTA), INFRARENAL ABDOMINAL AORTA (AA), DISTAL ARCH OF AORTA INCLUDING THE LEFT SUBCLAVIAN ARTERY. THERE WAS ¿DOUBLE RING¿ SIGN ON CTA POST-CONTRAST IMAGES SUGGESTIVE OF ACTIVE INFLAMMATORY DISEASE. HER ERYTHROCYTE SEDIMENTATION RATE (ESR) AND C- REACTIVE PROTEIN (CRP) LEVELS WERE RAISED. A POSSIBILITY OF MYOCARDITIS WAS CONSIDERED AS A CAUSE OF LV DYSFUNCTION LEADING TO HEART FAILURE ESPECIALLY ON THE BACKGROUND OF ACTIVE INFLAMMATION, HOWEVER HER TROPONIN T LEVELS WERE NORMAL, AND HER ECG WAS SUGGESTIVE OF LEFT VENTRICULAR HYPER-TROPHY WITH REPOLARIZATION ABNORMALITIES. SHE WAS TREATED WITH A COMBINATION OF AZATHIOPRINE AND PREDNISOLONE AS WELL AS ANTI-HYPERTENSIVES AND HEART FAILURE THERAPY. HER INFLAMMATORY MARKERS NORMALIZED ABOUT 12 MONTHS LATER; HOWEVER, LEFT VENTRICULAR DYSFUNCTION PERSISTED. SHE SUBSEQUENTLY UNDERWENT BALLOON ANGIOPLASTY WITH AN OPTION OF STENTING ONLY IF STRONGLY INDICATED. AORTOGRAPHY MEASURED DIAMETER OF NORMAL SEGMENT OF DTA TO BE 12 MM AND AA TO BE 7 MM. STENOTIC SEGMENTS MEASURED 4.63 AND 4.1 MM RESPECTIVELY. THERE WAS PRESSURE GRADIENT OF 30 MM HG ACROSS THE STENOTIC SEGMENT IN DTA AND 20 MM HG ACROSS THE SEGMENT IN AA. A 7 MM DIAMETER CUTTING BALLOON (BOSTON SCIENTIFIC, USA) WAS USED AND BOTH SEGMENTS WERE DILATED UP TO 5 ATMOSPHERE(ATM). BOTH LESIONS YIELDED WELL. PRESSURE GRADIENT ACROSS THE DTA SEGMENT WAS STILL >20 MMHG. SO, THIS SEGMENT WAS DILATED WITH10 MM DIAMETER BALLOON (ADVANCE BALLOON, COOK INC) AT 4 ATM. PRESSURE GRADIENT AFTER BALLOON ANGIOPLASTY WAS < 10 MM HG. THERE WAS NON-FLOW LIMITING DISSECTION AT THIS SEGMENT AFTER ANGIOPLASTY. IT WAS NOT STENTED AS THE DISSECTION WAS NOT EXTENSIVE. PATIENT WAS STARTED ON ASPIRIN, REMAINED CLINICALLY STABLE AND WENT HOME. ON DAY FOUR POST-PROCEDURE SHE DEVELOPED ACUTE PARAPARESIS (GRADE3 WEAKNESS) WITH ANURIC RENAL FAILURE (CREATININE 5 MG/DL). MAGNETIC RESONANCE ANGIOGRAPHY REVEALED AORTIC OCCLUSION AT THE DTA LEVEL WITH PSEUDOANEURYSM (26 × 15 MM) ADJACENT TO THE FLAP IN THE INFEROLATERAL ASPECT. ANGIOGRAPHY CONFIRMED THE FINDINGS AND SHE WAS MANAGED BY INSERTION OF STENTS. A SHORT-COVERED STENT (10 MM DIAMETER) WAS PLACED ACROSS THE PSEUDOANEURYSM AND A LONGER NON-COVERED STENT WAS USED TO COVER THE EXTENDED DISSECTION FLAP. SHE MADE COMPLETE CLINICAL RECOVERY AND HER RENAL FUNCTION BECAME NORMAL. PER THE AUTHORS, THIS CASE HIGHLIGHTS THE DIFFERENCE IN THE HISTOLOGY AND THEREBY THE BEHAVIOR OF THE AORTA TO ANGIOPLASTY IN AN INFLAMMATORY COARCTATION (SUCH AS IN TA) IN CONTRAST TO THE USUAL NON-INFLAMMATORY CONGENITAL (NATIVE) COARCTATION. NATIVE COARCTATION OF AORTA CONSISTS OF A THICK INTIMAL AND MEDIAL RIDGE WHICH PROTRUDES POSTEROLATERALLY INTO THE LUMEN. THERE IS ASSOCIATED MEDIAL DEGENERATION IN THE FORM OF MUCOID EXTRACELLULAR MATRIX ACCUMULATION (MEMA) ALONG WITH FRAGMENTATION OF ELASTIN FIBERS. BOTH FEATURES ARE SUBSTRATES FOR LATE DISSECTIONS AND ANEURYSM FORMATION AFTER BALLOON ANGIOPLASTY WHICH IS REPORTEDLY HIGH. IN CASE OF INFLAMMATORY COARCTATION, THERE IS PANARTERITIS WITH EDEMA, INFILTRATES AND GRANULOMATOUS GIANT CELLS IN THE ACUTE PHASE. LATE PHASE CONSISTS OF CHRONIC INFLAMMATION, TRANSMURAL FIBROSIS AND DISRUPTION OF ELASTIC FIBERS. THE INTIMA BECOMES THICKER THAN MEDIA THEREBY OBLITERATING THE LUMEN. PERSISTENT ACUTE INFLAMMATION CAUSES VESSEL DILATATION AND FORMATION OF ANEURYSM, BUT STENOSIS IS MORE COMMONLY SEEN IN THE CHRONIC PHASE. WALL FIBROSIS MAKES THE VESSEL LESS LIKELY TO DISSECT AFTER BALLOON ANGIOPLASTY, BUT HIGHER BALLOON INFLATION PRESSURES AND MULTIPLE AND PROLONGED DILATATIONS MAY BE REQUIRED FOR THE LESION TO YIELD. THIS HIGH-PRESSURE DILATION CAN RESULT IN AORTIC DISSECTION AND RUPTURE. THE TRANSMURAL SCARRING CAN BE RESISTANT TO PLAIN BALLOON ANGIOPLASTY AS THERE IS RESIDUAL STENOSIS DUE TO RECOIL. HENCE CUTTING BALLOONS ARE USED TO OVERCOME THE RESIDUAL STENOSIS. DIFFUSE ADJACENT DISEASE (VERSUS DISCRETE STENOSIS IN NATIVE NON-INFLAMMATORY COARCTATION), ECCENTRIC STENOSIS AND CALCIFICATION PREDICT BAD OUTCOMES OF BALLOON ANGIOPLASTY IN TA IN THE FORM OF DISSECTION AND/OR OBSTRUCTION. IN OUR PATIENT, EVEN THOUGH MULTIPLE SUSTAINED DILATATIONS WERE GIVEN TO THE DTA AFTER USING A CUTTING BALLOON, THE PRESSURES USED WERE NOT HIGH (4 ATM). NON-FLOW LIMITING DISSECTION EXTENDED TO PSEUDOANEURYSM OVER A SHORT TIME SPAN. WHEN WE REVIEWED THE IMAGES, WE OBSERVED THAT THE DISSECTION FLAP ON THE LATERAL AORTIC WALL WAS DOWNWARD LOOKING, IN THE DIRECTION OF AORTIC FORWARD FLOW AND THE EXTENSION OF DISSECTION BEYOND THE VESSEL MEDIA AND THE DIRECTION OF FLOW WOULD HAVE RESULTED IN RAPID PROGRESSION AND FORMATION OF PSEUDOANEURYSM. HOW MUCH ROLE VESSEL INFLAMMATION PLAYS IN THE PROGRESSION IS ALSO WORTH INVESTIGATING. COMMONLY USED INFLAMMATORY MARKERS SUCH AS ESR AND CRP WERE NORMAL IN OUR PATIENT BEFORE PROCEDURE. HOWEVER, THESE ARE NOT PERFECT MARKERS OF DISEASE ACTIVITY IN TA. ACTIVE DISEASE CAN PERSIST IN THE ABSENCE OF ELEVATED BIOMARKERS. SEVERAL BIOMARKERS HAVE BEEN PROPOSED FOR MEASUREMENT OF DISEASE ACTIVITY LIKE NF-ALPHA, IL-6, IL-18 AND PENTRAXIN-3 (PTX-3) LEVELS. O¿CONNOR ET AL HAVE REPORTED VARIOUS IMAGING MODALITIES THAT ARE USEFUL FOR MONITORING REMISSION, RELAPSE, AND SUBCLINICAL PROGRESSION OF DISEASE AS WELL AS FOR DEMONSTRATING THE EFFECTIVENESS OF THERAPY. THEY INCLUDE CT AND MR ANGIOGRAPHY AND POSITRON EMISSION TOMOGRAPHY (PET). OUR PATIENT HAD ¿DOUBLE RING¿ SIGN ON THE CTA DONE ONE YEAR AGO DURING ACTIVE DISEASE, WHERE INNER RING REPRESENTS THE POORLY ENHANCED SWOLLEN INTIMA AND THE OUTER ENHANCED RING INDICATES ACTIVE INFLAMMATION IN MEDIA AND ADVENTITIA. WE HYPOTHESIZE THAT THE PRESENCE OF LURKING INFLAMMATION COULD HAVE CONTRIBUTED TO THE RAPID PROGRESSION OF MINOR DISSECTION IN THIS PATIENT. CT ANGIOGRAPHY IMMEDIATELY BEFORE INTERVENTION WOULD HAVE PROBABLY GIVEN A CLUE OF PERSISTING INFLAMMATION DESPITE THE NEGATIVE BIOMARKERS, WHICH WAS NOT DONE IN OUR CASE. A FEW CASES OF AORTIC RUPTURE FOLLOWING ANGIOPLASTY OF TA HAVE BEEN DESCRIBED PREVIOUSLY AS REPORTED BY MEHTA ET AL, WHEREIN MOST OF THE CASES WERE RE-DO CASES WITH A PRIOR HISTORY OF INTERVENTION EITHER IN THE FORM OF SURGERY OR ANGIOPLASTY. THE INDEX CASE (WITH NEGATIVE INFLAMMATORY MARKERS) DESCRIBED BY MEHTA ET AL WAS AN AORTIC RUPTURE THAT OCCURRED ON TABLE AT THE TIME OF FIRST INTERVENTION. IN OUR CASE TOO, THE COMPLICATION OCCURRED AFTER THE FIRST INTERVENTIONAL PROCEDURE; ALBEIT FOUR DAYS LATER IN THE FORM OF OBSTRUCTING DISSECTION AND PSEUDOANEURYSM PRESENTING AS PARAPARESIS AND ACUTE RENAL SHUTDOWN. THE AUTHORS CONCLUDE RAPID PROGRESSION OF MINOR DISSECTION OCCURRING AFTER BALLOON ANGIOPLASTY IS POSSIBLE IN INFLAMMATORY AORTOARTERITIS, LEADING TO AORTIC OCCLUSION. THIS REPORT IS SUBMITTED FOR THE UNSPECIFIED COOK BALLOON USED DURING THE ANGIOPLASTY PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 703278 | ADVANCE 35 LP LOW PROFILE BALLOON CATHETER | DQY CATHETER, PERCUTANEOUS | DQY | COOK INC | 5943393 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |