Catalog Number CDS0705-XTW |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional cds0705-xtw device referenced in b5 is filed under separate medwatch report number (b)(4).
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Event Description
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It was reported that on (b)(6) 2024, a patient presented with grade 4 degenerative mitral regurgitation (mr), small posterior mitral leaflet (pml), and opposing extensive anterior mitral leaflet (aml) flail from a ruptured primary chordae (the flail involved the majority of a2 scallop and extending to a3) for a mitraclip procedure.During grasping with a mitraclip xtw (31206r1091), a broken gripper line was observed.The clip was removed and replaced.The replacement mitraclip xtw (31031r1006) was the first clip implanted successfully and was well-inserted post-deployment.It was noted that the first clip had movement on the leaflets due to the residual redundant tissue/ flail.A second clip (30726r1119), an ntw was attempted to be placed to further reduce the mr and stabilize the movement of the first clip.By the time the second clip was ready to insert it was noted that the pml had started to slip from the first implanted clip (31031r1006).A rocking motion was observed from the first clip.A single leaflet device attachment (slda) was witnessed on both fluoroscopy and transesophageal echocardiogram (tee).The pml was detached.Per the physician, the slda was due to extensive aml flail, residual pathology, and the rocking motion of the clip causing pressure on the grasping area.After the detachment, the slda clip made contact with the second clip.The continuous motion of the slda and the short pml contributed to the inability to grasp and capture with the second clip.The second clip did not contribute to the slda.The procedure was discontinued and the mr was grade 4.The patient will require mitral valve surgery.A surgical decision has not been determined due to thrombocytopenia.Per the physician, thrombocytopenia was due to heparin and sepsis, and not related to the mitraclip or the procedure.On (b)(6) 2024, a mitral valve replacement with a bioprosthetic was performed.Additionally, atrial septal defect (asd) closure was performed.In the physician's opinion, the asd noted during surgery was caused by the steerable guide catheter (sgc) during the mitraclip procedure.The patient is doing well with no post-operative complications.
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Manufacturer Narrative
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All available information was investigated, and the reported broken gripper line was confirmed via returned device analysis.Additionally, the lock line was observed to be frayed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the cause of the reported broken gripper line and observed frayed lock line were unable to be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Event Description
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It was reported that on (b)(6) 2024, a patient presented with grade 4 degenerative mitral regurgitation (mr), small posterior mitral leaflet (pml), and opposing extensive anterior mitral leaflet (aml) flail from a ruptured primary chordae (the flail involved the majority of a2 scallop and extending to a3) for a mitraclip procedure.During grasping with a mitraclip xtw (31206r1091), a broken gripper line was observed.The clip was removed and replaced.The replacement mitraclip xtw (31031r1006) was the first clip implanted successfully and was well-inserted post-deployment.It was noted that the first clip had movement on the leaflets due to the residual redundant tissue/ flail.A second clip (30726r1119), an ntw was attempted to be placed to further reduce the mr and stabilize the movement of the first clip.By the time the second clip was ready to insert it was noted that the pml had started to slip from the first implanted clip (31031r1006).A rocking motion was observed from the first clip.A single leaflet device attachment (slda) was witnessed on both fluoroscopy and transesophageal echocardiogram (tee).The pml was detached.Per the physician, the slda was due to extensive aml flail, residual pathology, and the rocking motion of the clip causing pressure on the grasping area.After the detachment, the slda clip made contact with the second clip.The continuous motion of the slda and the short pml contributed to the inability to grasp and capture with the second clip.The second clip did not contribute to the slda.The procedure was discontinued and the mr was grade 4.The patient will require mitral valve surgery.A surgical decision has not been determined due to thrombocytopenia.Per the physician, thrombocytopenia was due to heparin and sepsis, and not related to the mitraclip or the procedure.On (b)(6) 2024, a mitral valve replacement with a bioprosthetic was performed.Additionally, atrial septal defect (asd) closure was performed.In the physician's opinion, the asd noted during surgery was caused by the steerable guide catheter (sgc) during the mitraclip procedure.The patient is doing well with no post-operative complications.
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Search Alerts/Recalls
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