MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number UNK CDS

Device Problems Incomplete Coaptation (2507); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

The clip remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.B3: the event date was estimated.D6a the implant date was estimated.

Event Description

This is filed to report a single leaflet device attachment (slda).It was reported that a mitraclip procedure was performed in (b)(6).On (b)(6) 2023, a single leaflet device attachment (slda) occurred.A second clip intervention has been scheduled.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because no lot information was provided.Based on available information, the reported increased mr was due to disease progression.The reported patient effect of mitral regurgitation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The procedure date in b5 was estimated.The implant date in d6a was estimated.

Manufacturer Narrative

The procedure date in b5 was estimated.The implant date in d6a was estimated.4582 - no clinical signs, symptoms, or conditions 2199 - no consequences or impact to the patient.2507 incomplete coaptation.

Event Description

Subsequent to the initial mdr.On (b)(6) 2023 a mitraclip procedure was performed.More than 90 days later, the patient presented with recurrent mr from disease progression.A chordae was ruptured.A single leaflet device attachment (slda) was suspected, but echocardiogram confirmed that the clip was on both leaflets.Per the physician, the recurrent mr and the chordae rupture was not caused by the mitraclip.There were no adverse patient effects or device malfunctions caused by the implanted mitraclip.No additional information was provided.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• 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: 17020666
• MDR Text Key: 316206413
• Report Number: 2135147-2023-02346
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2023

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: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/30/2023
• Supplement Dates Manufacturer Received: 06/20/2023; 07/07/2023
• Supplement Dates FDA Received: 07/10/2023; 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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