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

Catalog Number SGC0302

Device Problem Difficult to Advance (2920)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/27/2020

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.

Event Description

This is filed to report a hemorrhage.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3.The steerable guide catheter (sgc) was inserted and advanced into the right atrium (ra).It was noted that some resistance was felt when inserting the sgc.Approximately three minutes after the sgc was inserted, the patients blood pressure dropped to 60mmhg.Contrast was inserted and it was noticed that in the groin, a ruptured vein occurred.It was suspected that the sgc caused the ruptured vein.The sgc was removed and the bleeding was able to be temporarily covered with a balloon catheter, but the patient had to undergo surgical intervention to treat the ruptured vein.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 issue.A review of the compliant history identified no other incident reported from this lot.Based on information reviewed, a cause for the reported difficulty advancing the steerable guide catheter (sgc) could not be determined.Reportedly, it was noticed that in the groin, a ruptured vein occurred.It was suspected that the sgc caused the ruptured vein.Therefore, the reported hemorrhage appear to be result of reported difficult to insert.Additionally, reported patient effect of hemorrhage is listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures.The reported additional therapy/nonsurgical treatment, surgical procedure and hospitalization was a result of case specific circumstances as bleeding was able to be temporarily covered with a balloon catheter, the patient was hospitalized and had to undergo surgical intervention to treat the ruptured vein.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: 11047578
• MDR Text Key: 222703698
• Report Number: 2024168-2020-10763
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00908U106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention