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

Model Number SGC0301

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

Patient Problem Atrial Perforation (2511)

Event Date 08/14/2020

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 clip delivery system device is filed under a separate medwatch report.

Event Description

This is filed to report the atrial septal defect.It was reported that the patient presented in critical condition with right heart failure, dilated left atrium and mitral regurgitation.Prior to the mitraclip procedure, the patient had been hospitalized for two weeks and was expected to continue with a prolonged hospitalization post mitraclip procedure.The mitraclip procedure was performed to treat mixed mitral regurgitation (mr) with a grade of 4+.First, an ntw clip was implanted.A second clip delivery system (cds) was advanced and placed on the leaflets; however, when closing the clip to perform leaflet insertion, the patient¿s heart rate increased, blood pressure dropped, ekg changes were noted, and the patient went into cardiogenic shock.Cardioversion was performed, a balloon pump was inserted, and the patient stabilized.The cds and was removed without deploying the clip.Mr was reduced to 3.Per the physician, the patient did not tolerate the mitraclip procedure very well due to their presenting critical condition.After removal of the mitraclip system, the atrial septal defect (asd) was closed with a closure device.Post procedure, the patient was stabilized in improved condition.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have influenced the reported issues.The reported patient effect of atrial septal defect requiring intervention as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Based on the available information, the reported atrial perforation was due to a combination of challenging anatomy and procedural conditions.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• 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: 10491894
• MDR Text Key: 205713165
• Report Number: 2024168-2020-07388
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2021
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 00212U104
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP(X1); STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 94