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

Catalog Number CDS0706-XT

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

This report is being filed due to a device leak and air embolism, requiring treatment.Crd_947 - repair mr ide study patient id: (b)(6) it was reported that on (b)(6)2024, the patient presented with degenerative mitral regurgitation (mr) grade 4, an enlarged left atrium, mitral leaflet calcification, and posterior leaflet flail.The first mitraclip was successfully delivered and deployed, reducing the mr.The second mitraclip delivery system ((cds) cds0706-xt, 30928r1105)) was prepared for use.Reportedly, the technician over tightened the 3-way stopcock, causing the flush port to crack, however, this was not observed at the time.The cds advanced into the first steerable guide catheter (sgc) when an air embolism was observed traveling to the right coronary artery (rca).The patient became hypotensive, and epinephrine was provided.The cds was removed, and aspiration performed the sgc.The same cds was re-introduced, and the issue occurred again (loss of column with the sgc).The mitraclip was not implanted and both devices were removed.A second sgc was prepped for use and advanced.The same complaint cds was re-introduced when the second sgc also lost column.The devices were removed, and all devices were tested on the back table.It was then observed that the complaint cds had a cracked flush port.Both the first and second sgc used were able to hold fluid column without any leak, and without any device malfunction when tested with a new cds.The same second sgc was re-introduced and a new mitraclip advanced.The mitraclip was successfully delivered and deployed, reducing the mr to trace.There were no additional complications.The patient had stabilized without additional sequela.

Manufacturer Narrative

All available information was investigated, and the reported cracked flush port was confirmed via returned device analysis.The reported leak could not be replicated in a testing environment.Additionally, the flush port was observed to be broken.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 reported cracked flush port was due to procedural circumstances.The reported broken flush port luer was likely a cascading event of the reported cracked flush port and post-procedural shipping/handling.The reported leak was a cascading event of the reported cracked flush port luer.The reported air embolism was a cascading event of the reported leak.The reported hypotension was a cascading event of the reported air embolism.The reported patient effects of embolism and hypotension, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported medication required and unexpected medical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
• 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: 19011806
• MDR Text Key: 339081904
• Report Number: 2135147-2024-01404
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 05415067037404
• UDI-Public: 05415067037404
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/12/2024

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: CDS0706-XT
• Device Lot Number: 30928R1105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 05/28/2024
• Supplement Dates FDA Received: 06/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• 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: 2 STEERABLE GUIDE CATHETERS
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White