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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number B1070-080
Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915)
Patient Problems Vessel Or Plaque, Device Embedded In (1204); Death (1802); Embolism (1829)
Event Date 05/16/2017
Event Type  Death  
Manufacturer Narrative
(b)(4). The separated piece had embolized distally and was secured against the vessel wall bifurcation via deployment of an unspecified stent to prevent further movement downstream. The final result was good and the patient did well for 3 to 4 days post-procedure. However, the patient expired 5 to 7 days post-procedure due to many other unspecified comorbidities. In the opinion of the physician, while the patient comorbidities were a factor in patient death, it cannot be stated with certainty that the reported difficulties that occurred during the intervention did not contribute to patient death, as well. A review of the received cine image confirmed the reported device issue. No additional information was provided. Concomitant medical products: guide wire: storque cordis, sheath: cordis 6f, stent: everflex. (b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that on (b)(6) 2017, the procedure was to treat a 100% restenosed, moderately calcified lesion in the external iliac artery. Pre-dilatation was performed in the external iliac artery with an unspecified balloon, followed by placement of a non-abbott stent. Post-dilatation was performed with a 7. 0mm x 80mm x 80cm armada 35 balloon dilatation catheter (bdc) via two gentle inflations (no forced pressure applied) to an unknown pressure with a 10ml syringe. An attempt was then made to retract the armada 35 back into the 6f non-abbott introducer sheath, but it was unable to be completely retracted into the sheath. Imaging showed that approximately 2cm of the balloon was retracted inside of the sheath. As the balloon was not completely deflated (emptied of contrast), an attempt was made to completely deflate the balloon using a syringe with negative pressure pulled while simultaneously pulling the armada 35 balloon into the sheath, but the balloon still could not be pulled completely back into the sheath. An attempt was then made to remove the armada 35 and sheath as a single unit, but both were also unable to be removed, for a reportedly unknown reason. Force was applied when the balloon tip along with about 6cm of the balloon separated inside of patient anatomy. Attempts were made to snare the separated piece from patient anatomy from two access sites (one per side), but the attempts failed and resulted in flared stent struts for the implanted iliac stents from a prior intervention, and resulted in a 2-hour delay, but the delay did not result in a significant health impact. There was no other damage to the previously implanted stents and no additional intervention required to treat the the flared struts.
 
Manufacturer Narrative
(b)(4). Case description continued: an attempt was then made to remove the armada 35 and sheath as a single unit, but both were also unable to be removed, for a reportedly unknown reason. Force was applied when the balloon catheter tip along with about 6cm of the balloon separated inside of the patient anatomy. Attempts were made to snare the separated piece from the patient anatomy from two access sites (one per side) using snare devices and two guide wires. The attempts failed, resulting in additional blood loss (1. 5 l) through sheath and snaring devices. The failed snaring attempts also reportedly broke two kissing stents previously placed in an aortic bifurcation in a prior intervention, and resulted in a 2-hour delay, but the delay did not result in a significant health impact. The broken stents were treated via deployment of two additional kissing stents. The separated piece of the balloon had embolized distally and was secured against the vessel wall bifurcation via deployment of an unspecified stent to prevent further movement downstream. During the entire intervention hemoglobin (hb) decreased from pre-interventional 12. 9 g/dl to a minimum of 4. 3 g/dl which led to massive transfusion and treatment with fibrinogen and vitamin k. Patient needed 4500 ml volume and catecholamines (up to a maximum of 37 mcg noradrenalin/min). After intervention, the patient was awake and in the intensive care unit. The final result was good with good blood flow through both iliac vessels. The following night, the patient experienced acute critical ischemia in the right external iliac and emergent aorto-bifemoral y-graft surgery was performed with endarterectomy of both common femoral arteries. During surgery the abdominal aorta was infrarenal and suprarenal disconnected. The patient was treated with noradrenal up to 30 mcg/min maximum. The patient lost 1300 ml blood during surgery. Substitution with 4 erythrocyte concentrate was performed when hb decreased to 3. 7g/dl. For optimization of coagulation the patient was treated with 1g tranexamic acid and 2 g haemocomplettan. After surgery the patient was sedated, intubated, and showed sufficient circulation. Duplex sonography showed critical ischemia and the physician assumed occlusion of the right superficial femoral artery (sfa) which was confirmed by angiographical computerized tomography. The exact cause of ischemia was unable to be determined. Aorto-bifemoral y-graft was open. On (b)(6) 2017, right sfa was retrograde recanalized via access from the right popliteal artery. Nevertheless, blood flow below the knee and of the right foot did not improve. Therefore on (b)(6) 2017, antegrade angioplasty and stenting of the popliteal was performed. Angiogram showed successful dilatation. The patient was treated with increasing catecholamins up to 100 mcg/min noradrenalin for hemodynamic stabilization. The patient exhibited tachycardic atrial fibrillation that was treated with amiodarone antiarrhythmic medication. The patient showed signs of liver failure and muscle fiber death due to ischemia. Moreover the patient showed anuretic renal failure and dialysis was started (b)(6) 2017. Hemoglobin continued to decrease, despite additional medication (erythrocyte concentrates). Additionally therapy with antibiotic imipenem was started to treat bacterial intestinal translocation. Treatment with aspirin and heparin was interrupted because of thrombocytopenia. In the night from (b)(6) 2017 to (b)(6) 2017, oxygenation was impaired despite artificial respiration to a maximum and prone position. Sonography confirmed a pleural effusion on the left side which could not be punctured because of the thrombocytopenia. Improvement of artificial respiration with sustained low-efficiency dialysis could also not be performed due to thrombocytopenia. The patient expired (b)(6) 2017, due to multi-organ failure. In the opinion of the physician, while the patient comorbidities were a factor in patient death, it cannot be stated with certainty that the reported difficulties that occurred during the intervention did not contribute to patient death, as well. No additional information was provided. Though requested, patient information (age, date of birth, weight, or gender) was not provided due to personal data protection national legislation. Evaluation summary: visual, dimensional and functional inspections were performed on the returned device. The deflation issue, and difficulty removing were unable to be confirmed due to the condition of the returned device. The balloon rupture and separations were confirmed. Based on the reported information, analysis of the returned product, and investigation details, the reported difficulties appear to be due to case circumstances. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that contributed to this event. Additionally, a review of the complaint history revealed no other incidents. A cine was received and reviewed by a clinical specialist who concluded the following: based on the comments received it appears that the device was not inflated using a calibrated inflation device, such as an indeflator, and was inflated multiple times manually using a syringe. Without using a calibrated inflation device, the user would not have been able to confirm the inflation pressure. While it may be possible to manually overinflate the device with a syringe, causing a rupture, it is more likely that the balloon was inflated to a low pressure. As the device was used within a previously implanted non-abbott self-expanding stent it is likely that the balloon interacted with the stent during the manual inflation by syringe and was damaged during that process, leading to the reported rupture. The armada 35 instruction for use (ifu) states: do not advance the armada 35 / armada 35 ll pta catheter against significant resistance. The cause of resistance should be determined via fluoroscopy and remedial action taken. In this case, removal against resistance was necessary to remove rupture balloon due to the case difficulties. Although a definitive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined, surgical procedure, ischemia, embolism, hypotension, renal failure, and death are listed as known potential complications in the armada 35 instruction for use (ifu). The investigation determined the reported difficulties appear to be related to circumstances of the procedure. A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Updated case description it was reported that on (b)(6) 2017, the procedure was to treat a 100% restenosed, moderately calcified lesion in the external iliac artery. Pre-procedure, the patient showed peripheral artery occlusive disease stage iii on both sides with problems on multiple levels (iliacal, femoral, popliteal, crural). During intervention of the left external iliac artery with an unspecified non-abbott device, the artery ruptured, resulting in severe bleeding (1. 5 liters (l) blood loss) and hemorrhagic shock. The rupture was closed with an unspecified stent graft. Pre-dilatation was then performed in the right external iliac artery with an unspecified balloon, followed by placement of a non-abbott stent. Post-dilatation was then performed in the right external iliac artery stent with a 7. 0mm x 80mm x 80cm armada 35 balloon dilatation catheter (bdc) via two gentle inflations (no forced pressure applied) to an unknown pressure with a 10ml syringe when the balloon ruptured. An attempt was then made to retract the armada 35 back into the 6f non-abbott introducer sheath, but it was unable to be completely retracted into the sheath. Imaging showed that approximately 2cm of the balloon was retracted inside of the sheath. As the balloon was not completely deflated (emptied of contrast), an attempt was made to completely deflate the balloon using a syringe with negative pressure pulled while simultaneously pulling the armada 35 balloon into the sheath, but the balloon still could not be pulled completely back into the sheath.
 
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Brand NameARMADA 35 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key6659156
MDR Text Key78124702
Report Number2024168-2017-05250
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue NumberB1070-080
Device Lot Number70124G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/12/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/21/2017 Patient Sequence Number: 1
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