MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Mitral Regurgitation (1964); Respiratory Distress (2045); Tissue Damage (2104)

Event Date 02/06/2020

Event Type  Injury  

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.The investigation was unable to determine a conclusive cause for the tissue damage and respiratory distress.The increased mr appears to be related to the tissue damaged.The reported hospitalization and additional therapy/non-surgical treatment were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.The steerable guide catheter device referenced is filed under a separate medwatch report number.

Event Description

Patient id: (b)(6).This report is filed due to increased mitral regurgitation with chordae rupture, requiring treatment.It was reported that on (b)(6) 2020, the patient presented with degenerative mitral regurgitation (mr) grade 4+, a posterior leaflet prolapse and flail.Two mitraclips ( cds0701-xtw, 91021u117 and 91021u121) were implanted without a device issue, reducing the mr to grade 1+-2+.On (b)(6) 2020, at the time of discharge the patient became hypoxic on exertion.Prolonged hospitalization was required.On (b)(6) 2020, per imaging, the mr had increased to grade 4+.The clips had remained stable, however, secondary chordae of the p2 leaflets, attached to the most lateral clip, had ruptured.Reportedly, it is unknown which implanted clip had the associated ruptured chordae.A residual bidirectional iatrogenic atrial shunt was also observed.As treatment, another mitraclip was implanted, reducing the mr to mild, and an atrial septal defect (asd) occluder was placed.The event resolved without sequela.No additional information was provided regarding this issue.

Event Description

Subsequent to the previous medwatch report, the additional information was obtained: on(b)(6)2020, a partial single leaflet device attachment (slda) and a torn cordae was observed, associated with the lateral clip, cds0701-xtw, 91021u121.

Manufacturer Narrative

The investigation is not yet complete.A follow-up report will be generated, reporting all additional relevant information.D4: lot number h6: device code 2993 removed.

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.It should be noted that the reported patient effects of tissue damage, mitral regurgitation (mr), and respiratory distress, as listed in the mitraclip system gen 4, instructions for use, are known possible complications associated with mitraclip procedures.The investigation was unable to determine a conclusive cause for the clip migration.The tissue damage, worsening mr and respiratory distress appear to be due to the procedural condition of the clip migration.The reported hospitalization and additional therapy/non-surgical treatment were results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.H6 : device code 2993 removed, result code: 213 removed.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9783085
• MDR Text Key: 183884221
• Report Number: 2024168-2020-01979
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2020

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 Expiration Date: 04/19/2020
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 91021U121
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 08/05/2020; 09/16/2020
• Supplement Dates FDA Received: 08/25/2020; 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 82