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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC UNKNOWN

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COOK INC UNKNOWN Back to Search Results
Catalog Number UNKNOWN
Device Problem Material Rupture (1546)
Patient Problems Aneurysm (1708); Death (1802); Rupture (2208)
Event Date 11/07/2017
Event Type  Death  
Manufacturer Narrative
Investigation ¿ evaluation the coda balloon devices were not returned. Without the complaint device, a physical investigation was not able to be completed. A document based investigation has been performed. A review of procedure videos, complaint history, the device history records, drawings, instructions for use, and quality control data was conducted. By the event report, the patient did not receive a pre-implantation computerized tomographic angiography (cta) because of hemodynamic instability. The rupture of two coda balloons, likely coda -2-10. 0-35-120-32s, from over expansion is confirmed. Thoracic aortic rupture likely occurred before balloon rupture as indicated by the sudden change in balloon shape as the aortic wall yielded as well as the initial flow of contrast down the aortic lumen rather than out the thoracic tear. The balloon's inability to seal at the same diameter that had just been successful was likely secondary to blood flow through the dissection imaged after the rupture. Although the dissection could have been caused by the rupture, its stability throughout the remainder of the case indicated that it was distinct from the rupture. If caused by the rupture, it should have dissipated with the ensuing extravasation. The dissection could have been easily caused by attempts to pass a wire between the aorta and the fully expanded balloon, sliding an inflated balloon along the wire, and/or over expansion of the 24mm suprarenal abdominal aorta to 34mm. The long case length, the certainty of dialysis, and the severe aneurysmal disease do not support omission of thoracic angiography prior to coda balloon inflation in the interest of time or renal preservation. Significant findings relative to the patient's anatomy were observed. Aneurysmal disease was severe. The distal thoracic aorta was dilated to 40mm just proximal to a 24mm in diameter abdominal aorta. Significant findings relative to the disease state were observed. The lack of visceral perfusion and the extensive abdominal aortic aneurysm thrombus indicated a high post-operative mortality and renal failure even if the procedure had been promptly successful. Significant findings relative to the use of the device were observed. The balloons ruptured from over-expansion. Significant findings relative to the design or performance of the device were not observed. Cause of adverse events was observed. Thoracic aortic rupture leading to death likely occurred from over-dilation just prior to balloon rupture and not balloon rupture. Over-dilation, wire and catheter manipulation, and expanded balloon advancement in the suprarenal aorta likely caused the dissection. This dissection was likely responsible for the second balloon's inability to reestablish hemodynamic stability. Each product is shipped with instructions for use (ifu), listing the indications for use, contraindications, warnings and precautions. Per the ifu, ¿upon removal from package, inspect the product to ensure no damage has occurred. Do not exceed maximum inflation volume. Rupture of balloon may occur. Over-inflation of balloon may result in damage to vessel wall and/or vessel rupture. " the device history records were reviewed for the provided lot numbers 8172979, 8134150, 8191904, and 7888098. There were no nonconformances identified associated with the reported failure mode. A review of complaint history records was performed on all four provided lot numbers. Only one complaint report was identified and it is associated with lot number 8191904. The complaint is unrelated to the reported failure mode. Each coda balloon device is shipped with instructions for use (ifu), which specifies the maximum balloon inflation volume and provides instructions on balloon preparation, inflation, deflation and withdrawal. A video of the excluder implantation and thoracic aortic rupture were provided to the investigation for image review. Findings from the review include: active extravasation through a hole in the right side of the aneurysm, the inflation of a coda-2-10. 0-35-120-32 into the distal descending thoracic aorta with successful occlusion, aggressive wire and catheter manipulation to unsuccessfully pass a wire past the coda balloon, deflation, reflation, and advancement of the coda balloon, implantation of a gore excluder, a second coda balloon inflated to 34 mm in a 24mm suprarenal aortic segment in exchange for the original coda, advancement of the second balloon to the distal thoracic aorta and even more inflation, further unsuccessful vigorous attempts to pass a wire and catheter past the fully inflated the balloon. It was at this point that the balloon was deflated, reflated, and advanced back to its position in the distal descending thoracic aorta. However, inflation continued beyond the volume that the original coda was inflated to. The balloon's shape changed from the shape of tube to round, indicating that aortic wall had ruptured. The balloon ruptured upon further inflation to a diameter of 42mm. The dissection extended into the suprarenal aorta. A new balloon was reinserted into the proximal thoracic aorta, expanded beyond 45mm, and ruptured. This balloon was likely a coda-2-10. 0-35-120-32. A new balloon was used and the rupture was repaired. Imaging of the thoracic dissection repair was not provided or was not viewable. The impression of the image reviewer is that the coda balloons were ruptured due to over expansion. In addition, the thoracic aortic rupture likely occurred before balloon rupture as demonstrated by the change in balloon shape as the aortic wall yielded. The dissection could have, "been easily caused by attempts to pass a wire between the aorta and the fully expanded balloon, sliding an inflated balloon along the wire, and/or over expansion of the 24mm suprarenal abdominal aorta to 34mm. " the aneurysmal disease of the patient was severe as the distal thoracic aorta was dilated to 40mm. Based on the available information the root causes of the rupture and dissection are likely due to patient condition and user technique. A root cause of the balloon ruptures is likely product receiving excessive pressure. Per the quality engineering risk assessment, no further action is warranted. The appropriate personnel have been notified of this event. Monitoring will continue to be performed for similar complaints.
Manufacturer Narrative
Concomitant medical products: cook products used for this procedure: coda-2-10. 0-35-120-32 / lot # 8172979. Coda-2-10. 0-35-120-32 / lot # 8134150. Coda-2-10. 0-35-120-40 / lot # 8191904. Coda-2-10. 0-35-120-40 / lot # 7888098. Thsf-35-260-aus2 - amplatz support wire guide. Non-cook products used in this procedure: gore excluder trunk ipsilateral legs. Gore c-tag. (b)(4). The event is currently under investigation. A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event Description
As reported by the hospital, a (b)(6)-old male patient who complained of stomach pain was sent to the hospital urgently. He was diagnosed as having a ruptured abdominal aortic aneurysm (aaa). The patient had not been diagnosed or treated at this hospital for the aaa condition previously and the vessel condition including the possibility of dissection was not known. The patient went into shock and cardiac arrest. The patient underwent an urgent ruptured aaa repair using another manufacturer¿s stent grafts. Due to the unstable hemodynamic status, the physician could not conduct a computerized tomography (ct) scan, so he performed the procedure without knowing the size of the descending aorta. Interruption of blood flow in the descending aorta was performed by using the first coda balloon catheter. Then from the left common femoral artery (cfa), another manufacturer¿s stent graft was placed. Then a second coda balloon was inserted to this deployed graft¿s proximal neck to interrupt the blood flow. The doctor then deflated the coda balloon in the descending aorta. The hemodynamic status would not stay stable. So, the physician re-inflated the first coda balloon to interrupt blood flow but the balloon ruptured. He inserted a third coda balloon and inflated it in the descending aorta but this balloon ruptured as well. A dissection-like lesion was found in the descending aorta, and interruption of blood flow was completed using a fourth coda balloon by placing it at the proximal side of the dissection-like lesion. Additional stent grafts were placed in both the left and the right side. Digital subtraction angiography (dsa) was performed confirming dissection and rupture of the descending aorta. After interrupting the blood flow in the proximal side, another manufacturer¿s stent graft was placed to treat the dissection and the rupture of the descending aorta. Then the interrupted blood flow in the proximal side was released, but the blood pressure would not increase. Control of the dissection and the rupture became unstable. The patient then went into cardiac arrest. Cardiac massage was performed but the patient expired. No autopsy was performed but the physician stated that they suspect the death was a result of the ¿breakdown of hemodynamic status. ¿ the coda balloon catheter will not be being returned. The first balloon reported to rupture during this event has been captured in mfr report # 1820334-2017-04256. The report is for the second reported balloon rupture.
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Manufacturer (Section D)
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
MDR Report Key7102629
MDR Text Key106278521
Report Number1820334-2017-04257
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/10/2017 Patient Sequence Number: 1