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

Catalog Number UNK SGC03

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

Patient Problems Death (1802); Respiratory Distress (2045); Heart Failure (2206); Atrial Perforation (2511)

Event Date 06/06/2020

Event Type  Death  

Manufacturer Narrative

Date of event/death - estimated.The unique device identifier (udi) is unknown because 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 no device/lot information was provided.The reported patient effects of death, atrial perforation, heart failure and respiratory distress as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the available information, a definitive cause for the reported death appears to be procedure related.Furthermore, a definitive cause for the reported patient effects of atrial perforation, heart failure and respiratory distress could not be determined.Although, a conclusive cause for the reported patient effects, and the relationship to the device, if any, cannot be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.

Event Description

This is filed to report the patient death.It was reported that a mitraclip procedure was performed to treat mitral regurgitation.The procedure was successful, one clip was implanted successfully.The case went very well.However, after the procedure as the patient recovered from anesthesia, right heart pressures increased resulting in a right to left shunt.Sometime over the weekend, the patient desaturated and died.There was no abnormal tearing of the septum besides the inherent septal access with steerable guide catheter.Per the physician the patient death is procedure related, due to the septal access, but it is unknown if the patient would have decompensated without the septal hole.No additional information was provided.

• Brand Name: MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10176883
• MDR Text Key: 195881173
• Report Number: 2024168-2020-05198
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2020
• 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): Death