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

Catalog Number SGC0302

Device Problem Unintended Movement (3026)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Atrial Perforation (2511); Pericardial Effusion (3271)

Event Date 05/18/2020

Event Type  Death  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

This is filed to report unintended movement, pericardial effusion and death.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.Prior to the procedure, it was noted that the patient presented to the hospital with late presentation myocardial infarction and developed papillary muscle rupture and flail of the posterior leaflet.It was noted that the patient was intubated and placed on intra-aortic balloon pump (iabp) and inotropic support.The physician decided to continue with a mitraclip procedure; therefore, the steerable guide catheter (sgc) was inserted.However, while removing the guide wire, due to tension on the device, the sgc slightly moved forward.It was then noticed that, the patients blood pressure decreased.A pericardial effusion was noted immediately after.Emergency pericardiocentesis was performed; however, no significant reduction of the effusion occurred.The decision was made to open the chest by surgery.A large holed was then noted at the base of the left atrium (la) appendage and was attributed to the insertion of the sgc.The patient then passed away due to the pericardial effusion.There was no clinically significant delay in the procedure.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 contributed to the reported event.A review of the complaint history identified no other complaints reported from this lot.All available information was investigated and the reported unintended movement of the steerable guide catheter (sgc) appears to be related to user technique/procedural circumstances.The reported death appears to be related to procedural circumstances.Additionally, the atrial perforation resulting in pericardial effusion and hypotension also appear to be a result of procedural circumstances.The reported patient effects of death, pericardial effusion, hypotension and cardiac perforation (atrial perforation), as listed in the instructions for use (ifu), are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.This event was further reviewed by an abbott vascular medical affairs director.The reviewer stated that the cause of patient¿s death is the surgical intervention but the pericardial effusion was the triggering factor leading to the cascade of events leading to the need of surgical intervention and ultimately death.It seems that the customer is alluding to the triggering factor and not the immediate cause of death which is obviously surgery.H6: code 2511 added.

• 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: 10128924
• MDR Text Key: 194343380
• Report Number: 2024168-2020-04786
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00225U134
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Weight: 102