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

Model Number SGC0301

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

Patient Problems Headache (1880); Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Shock (2072)

Event Date 12/24/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This is filed to report hypovolemic shock.It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr).Two clips were implanted without issue, reducing mitral regurgitation from 4 to 1-2.Approximately, four hours post procedure, the patient complained of generalized discomfort all over including headache and chronic leg pain.Small amount of oozing on right groin progressed to significant bleeding, with a small hematoma at the groin.The patient lost approximately one liter of blood, developed hypovolemic shock requiring aggressive resuscitation efforts including cardiopulmonary resuscitation, intubation and blood transfusion.Manual compression and a pressure device were used, resolving the bleeding issue and a good palpable pedal pulse on the right side was noted.No additional information was provided.

Event Description

It was reported that this was a mitraclip procedure to treat mitral regurgitation (mr).Two clips were implanted without issue, reducing mitral regurgitation from 4 to 1-2.Approximately, four hours post procedure, the patient complained of generalized discomfort all over including headache and chronic leg pain.Small amount of oozing on right groin progressed to significant bleeding, with a small hematoma at the groin.The patient lost approximately one liter of blood, developed hypovolemic shock requiring aggressive resuscitation efforts including cardiopulmonary resuscitation, intubation and blood transfusion.Manual compression and a pressure device were used, resolving the bleeding issue and a good palpable pedal pulse on the right side was noted.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.The reported patient effects of hemorrhage, hematoma, shock, pain and headache, as listed in the mitracip ifu, are known possible complications associated with mitraclip procedures.The investigation was unable to determine a conclusive cause for the hemorrhage.The hematoma, shock, pain and headache appear to be cascading effects of the hemorrhage; therefore, attributed to procedural conditions.There is no indication of a product issue with respect to manufacture, design, or labeling.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9662135
• MDR Text Key: 177596560
• Report Number: 2024168-2020-01137
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2020
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 90819U105
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM (X2); CLIP DELIVERY SYSTEM (X2)
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 73 YR