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

Catalog Number SGC0302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Perforation (2511)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The second clip delivery system referenced in is filed under separate medwatch report number.

Event Description

This is being filed to report that after removal of the steerable guide catheter (sgc), a right to left shunt at the septum was observed.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4+.The clip delivery system (cds) was advanced to the mitral valve and the clip was placed per the instruction for use (ifu).It was decided to add another clip to further reduce mr.The second cds was advanced to the mitral valve without issue and when grasping and performing leaflet insertion assessment (lia), a hematoma [thrombus] was noted outside the left atrium.Therefore, the clip was retracted the to the left atrium.Transesophageal echocardiography (tee) and transthoracic echocardiography (tte) was performed but no conclusion could be reached, so the second clip deployment was aborted.The cds was retracted from the patient anatomy.Computed tomography (ct) was performed after the procedure, but no hematoma was found.However, blood was noted adhered to the probe after it was removed.Additionally, a right to left shunt was confirmed after the steerable guide catheter (sgc) was removed.One clip was implanted, reducing mr to 2+.There was no treatment for the hematoma or shunt.The patient condition is stable.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the available information, a cause for the reported atrial perforation could not be determined.Additionally, atrial perforation is listed in the instruction for use (ifu) as a known possible complication associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10869115
• MDR Text Key: 217143621
• Report Number: 2024168-2020-09744
• 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: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00803U160
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1 IMPLANTED MITRACLIP; 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 76