MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number UNK SGC

Device Problem Failure to Advance (2524)

Patient Problem Perforation (2001)

Event Date 09/17/2023

Event Type  Injury  

Event Description

It was reported in an article that the patient underwent a mitraclip procedure to treat severe degenerative mitral regurgitation (mr) due to flail of the lateral (p1) scallop with a commissural jet.The transseptal puncture was performed in the mid-position in the bicaval view and in the mid-posterior position in the short-axis view, with a transseptal puncture height of 4 cm.The mitraclip system was noted to have an anterior-to-posterior trajectory (aorta hugger).Correcting the aorta hugger trajectory - using the ¿+¿ knob on the steerable guide catheter to move the guide posteriorly (away from the aorta) and the ¿m¿ knob to move the mitraclip system medially - resulted in loss of height of the mitraclip system from the mitral valve.The loss of height from the mitral valve could not be adequately corrected with posterior steering of the guide catheter and addition of the ¿a¿ knob to move the mitraclip system anteriorly and laterally to the mitral plane.A repeat transseptal puncture was performed with a transseptal height of 5.8 cm.While advancing the mitraclip steerable guide across the interatrial septum through the second transseptal puncture, a septal tear was noted, extending to the first transseptal puncture, thereby again resulting in loss of height from the mitral valve.Despite advanced steering with the a knob and m knob, as well as posterior steering of the guide catheter, an adequate height of the mitraclip system from the mitral valve could not be achieved and the aorta hugger trajectory could not be corrected.The procedure was aborted.Details are listed in the attached article titled, ¿transcatheter edge-to-edge repair with the pascal device for failed mitraclip procedure¿.

Manufacturer Narrative

Date of event is estimated.The udi number is not known as the part and lot numbers were not provided the device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no lot information was provided.Additionally, the complaint history review was not performed because this incident was based on an article review and no lot information was provided.Based on available information, the reported failure to advance (low transseptal puncture) associated with the low trajectory was due to the septum tearing, losing device height.The cause of the reported perforation (atrial: no treatment) associated with the septum tear could not be determined.The reported patient effect of perforation, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported serious injury/ illness/ impairment was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Attachment: article titled "transcatheter edge-to-edge repair with the pascal device for failed mitraclip procedure."na.

• Brand Name: MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
• 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: 17994560
• MDR Text Key: 326362524
• Report Number: 2135147-2023-04618
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Male