Catalog Number 1012580-19 |
Device Problems
Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)
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Patient Problems
Anemia (1706); Arrhythmia (1721); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Swelling (2091); Ventricular Fibrillation (2130); Respiratory Failure (2484); Test Result (2695)
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Event Date 03/09/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).During the surgery, an extra stiff wire was placed at the cath site to put patient on bypass machine.The three graftmaster stents were discovered to be outside of the lad, protruding into the pericardium.The three graftmaster stents were removed from the pericardium.Ligation of the lad was performed and the lad was bypassed via saphenous vein graft.Patient had 2 plus edema and gained 24 pounds (post operative weight was (b)(6)) between (b)(6) 2016 and (b)(6) 2016.The patient was extubated on (b)(6) 2016.As of (b)(6) 2016, weight is steadily declining with continued diuresis.Patient experienced acute anemia and thrombocytopenia due to blood loss, and received platelets on (b)(6) 2016.While there was a decline in hemoglobin value of 9.8 on (b)(6) 2016 to 9.2 on (b)(6) 2016, the patient hemoglobin was recovering and had a hemoglobin value of 9.6 at discharge.The patient was discharged with no adverse sequelae as of (b)(6) 2016.Reportedly, the two expired graftmaster stents had expired in february 2016, but the site did not have other graftmaster devices of those sizes on-hand; these expired stents were intentionally deployed due to the emergent need for use for this patient.No additional information was provided.(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products:guide wire: grand slam.Stent: 2.25x32 promus (boston scientific); 2.75x38 promus (boston scientific); 2.8x26 rx graftmaster; 2.8x19 rx graftmaster.Guide cath: guideliner.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The guidewire and graftmaster rx device(s) referenced are being filed under a separate manufacturing report number.
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Event Description
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It was reported that on (b)(6) 2016, the patient underwent a percutaneous coronary intervention to treat a chronic total occlusion in the mid to distal left anterior descending (lad) coronary artery via deployment of a 2.25x32 non-abbott stent in the most distal segment, then via deployment of a 2.75x38 non-abbott stent in the mid lad.Angiography showed a perforation with extravasation in the mid lad.Reportedly, while no guide wire device issues were noted with any of the guide wires used, the last guide wire used in the procedure (a grand slam wire) is believed to have contributed to the perforation, as the occluded vessel did not allow the wire to follow the vessel path.Pericardiocentesis was performed.The patient went into cardiac arrest and cardiopulmonary resuscitation (cpr) was initiated.A 2.8x19 rx graftmaster, then an expired 2.8x19 rx graftmaster, followed by an expired 2.8x26 rx graftmaster covered stents were each implanted in the lad in an attempt to seal the perforation with each deployment; after placement of each stent, there was still no improvement to bleeding.Cpr was continued and the patient redeveloped escape rhythm and intermittent sinus rhythm (arrhythmia).The patient intubated and was emergently transferred to the operating room for open heart surgery.The patient was in ventricular fibrillation at the start of surgery and was cardioverted back to a normal ventricular rhythm.Left ventricular (lv) function was very poor with severe global hypokinesis.The patient was allowed to recover via bypass machine for over 90 minutes and epinephrine was administered, improving blood pressure and lv function.
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Manufacturer Narrative
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(b)(4).Evaluation summary: a visual inspection was performed on the returned stent, but the catheter was not returned for analysis.The investigation was unable to determine a conclusive cause for the reported failure to seal the perforation or stent migration.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however the reported treatments appear to be related to the circumstances of the procedure.The reported patient effects of arrhythmia, hypotension and ventricular fibrillation as listed in the graftmaster rx coronary stent graft system, instructions for use (ifu), are known patient effects that may be associated with use of a coronary stent in native coronary arteries.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however the reported treatments appear to be related to the circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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