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

Model Number CDS0701-NTW

Device Problems Break (1069); Positioning Failure (1158); Unintended Movement (3026); Noise, Audible (3273)

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

Event Date 09/22/2022

Event Type  malfunction  

Event Description

This is filed to report unintended movement.It was reported that on (b)(6) 2022, a patient presented with grade 3-4 functional mitral regurgitation (mr) and a restricted posterior leaflet.The target was a2 and p2 leaflets.All functional testing of the mitraclip ntw passed.The ntw was advanced into the steerable guide catheter (sgc), and steered down to the valve using the m knob.The ntw had a slight lateral dive, and more m knob was added.The m knob was in the 5 o'clock position, and 1 more hour of rotation was added to the 6 o'clock position.The ntw abruptly moved to the straightened position while the m knob was still at 6 o'clock.No other knobs were engaged.The m knob was turned back to neutral, and there was no movement, and the device was steered down again with no movement.The ntw was removed and replaced with another device.There was no indication of an adverse patient effect and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

All available information was investigated, and the reported positioning failure and cable break were confirmed, but the reported audible noise was not confirmed (could not be replicated in a testing environment).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 incidents reported from this lot.Based on available information, the cause of the reported noise, audible (noise) and positioning failure (curve ¿ unable) are due to the m cable break.The cause of the reported break (cable break) could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: device code 3026 steerable sleeve issue was removed and 1158 curve- unable was added.

Event Description

Subsequent to the previous report, this event was re-evaluated to be not reportable.A clip delivery system (cds) cable break that impacts the ability to curve the cds is not known to cause or contribute to serious injury.Additionally, the cables are located within the sleeve of the cds and there is no potential for the broken cable to be left behind in the patient¿s anatomy.In the event of a cable break, the device can be removed.This would be inconvenient and may require replacement of the device but would not cause serious injury and is not reportable.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM
• 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: 15614389
• MDR Text Key: 302352272
• Report Number: 2135147-2022-01649
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648230967
• UDI-Public: 08717648230967
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2022
• Device Model Number: CDS0701-NTW
• Device Catalogue Number: CDS0701-NTW
• Device Lot Number: 11005R181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White