MAUDE Adverse Event Report: ABBOTT VASCULAR SGC03; VALVE REPAIR

Catalog Number SGC0302

Device Problems Improper or Incorrect Procedure or Method (2017); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Revised.It was reported that the mitraclip procedure was performed to treat mixed mitral regurgitation with grade of 4.The patient had a small anatomy with small atrium, the septal puncture was a huge problem and the height over the valve was 3.3 cm.The steerable guide catheter (sgc) was inserted and advanced into artery, per the instruction for use (ifu).The physician had to manipulate the clip delivery system (cds) to gain height to the mitral valve; therefore, more curves were applied to the cds than usual and tension was very high.Before clip deployment, the gripper line broke as due to too much tension.The procedure was aborted as the second cds would have the same issue.The cds with the clip attached and gripper line were removed.There were no clips implanted, mr remained at 4.There was no adverse patient effect and no clinically significant delay in the procedure.The cds was returned inside the sgc and analysis revealed that the sgc soft tip was torn.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported use after expiration could not be replicated in a testing environment as it was related to procedural conditions.It should be noted that, per the intended use section of the mitraclip system instructions for use (ifu) states: do not use the mitraclip nt system after the ¿use by¿ date stated on the packaging label, and never reuse or re-sterilize the system.The returned device analysis observed that the steerable guide catheter (sgc) soft tip was torn.A review of the lot history record revealed no manufacturing nonconformities to the reported lot.Additionally, a review of the complaint history identified no other complaints reported for the reported issue from this lot.Based on the available information, the reported use after expiration is related to user error; however, the use of expired product did not contribute to any device related reported issues.The observed tear in the sgc soft tip was due to procedural conditions.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: SGC03
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9823793
• MDR Text Key: 183125977
• Report Number: 2024168-2020-02314
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 81114U124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM