MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD); MITRAL VALVE REPAIR DEVICES

Catalog Number CDS0702-XTW

Device Problem Entrapment of Device (1212)

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Shock (2072); Cardiogenic Shock (2262); Multiple Organ Failure (3261); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)

Event Date 10/21/2023

Event Type  Death  

Event Description

It was reported that on (b)(6) 2023, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with grade 4, with a large posterior mitral leaflet flail.A mitraclip xtw (30801r1039) was advanced to the mitral valve but became caught in chordae.While attempting to remove the clip, the chordae appeared to be damaged.The clip was implanted with a good central tissue bridge and deployed on both leaflets.However, a large flail was still visible.The flail had worsened as it had appeared that the papillary muscle, which was part of the flail, was damaged.A mitraclip xtw (30620r1070) was then advanced to mitral valve and implanted.The procedure was completed with two clips implanted.The clips were stable on the leaflets.The mr remained at grade 4.On (b)(6) 2023, one day post procedure, the patient died due to being hemodynamically unstable.The patient had very low blood pressure.In the physician's opinion, the mitraclips did not cause or contribute to the patient death, but the pre-existing mr, which could not be improved, caused or contributed to the patient's death.The documented cause of death was due to multi organ failure due to septic and cardiogenic shock despite a non-abbott heart pump treatment.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip xtw device referenced in b5 is filed under separate medwatch report number.

Manufacturer Narrative

The device was not returned for analysis.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.The investigation was unable to determine a cause for the reported entrapment of device associated with clip caught on chordae.The reported tissue injury appears to be related to the clip caught on chordae.The reported unchanged mr appears to be related to the clip being deployed with chordae in conjunction with the tissue injury.The reported multiple organ dysfunction syndrome and cardiogenic shock appear to be related to pre-existing patient conditions.The reported hypotension, hypoxia, arrhythmia, and subsequent death appear to be due to multiple organ dysfunction syndrome and cardiogenic shock.Mr, tissue injury, multiple organ dysfunction syndrome, hypotension, cardiogenic shock, hypoxia, arrhythmia, and death are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported unexpected medical interventions were results of case specific circumstances as the clip was implanted with the chordae and an additional clip was implanted due to the unchanged mr.There is no indication of a product issue with respect to manufacture, design or labeling.This event was further reviewed by an abbott medical affairs director and the reviewer stated ¿please note that we have a still, mobile phone pics of the case (no color) which were not helpful in evaluating this case.From the narrative.The patient appears to have presented with a large flail posterior segment and possible concurrent papillary muscle rupture which was causing acute cardiogenic; this was done as a "bail out" procedure.It appears that the first xtw likely caused tissue injury which occurred when the clip was caught in the chords and during attempts to free it.This caused worsened mr and was not able to be successfully treated with a second clip.The patient's death was due to the underlying, existing cardiogenic shock (possibly due to post-infarct papillary muscle rupture although this is not absolutely clear).Urgent, "bail-out" teer with mitraclip was attempted but not successful.Please note that this case was not proctored, no abbott personnel were present.¿h6: code 2072 was removed.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18215142
• MDR Text Key: 329068851
• Report Number: 2135147-2023-05206
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDS0702-XTW
• Device Lot Number: 30801R1039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER
• Patient Outcome(s): Death