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

Catalog Number SGC0302

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

Patient Problems Tissue Damage (2104); Pericardial Effusion (3271)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Based on the information reviewed, the reported pericardial effusion appears to be due to procedural circumstances/user technique; however, tissue damage was a cascading effect of the effusion.Additionally, the reported additional therapy/non-surgical treatment and hospitalization appears to be due to case specific circumstances as pericardiocentesis was performed and prolonged hospitalization occurred.The reported patient effects of pericardial effusion and mitral valve injury (tissue damage) as listed in the mitraclip system instructions for use (ifu) are a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is being filed to report after the procedure, a pericardial effusion was noted.It was reported that this was a mitraclip procedure to treat mixed mitral regurgitation (mr) with a grade of 4.The septal puncture was difficult and there was difficulty getting a good height.A good puncture was managed at 2.3 cm above the annulus.The procedure was a little complicated and echocardiogram was suboptimal; however, the end results were good.Three clips were implanted reducing mr to 1.After the procedure, the patient suffered from pericardial effusion.The reason for the effusion was suspected due to the difficulty during the septal puncture, and the sgc might have stressed any small tear.Pericardiocentesis was performed.Hospitalization was prolonged and the patient remained stable with good mitraclip results.No additional information was provided.

• Brand Name: 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: 9443524
• MDR Text Key: 170037323
• Report Number: 2024168-2019-14328
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2019

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: 06/10/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90611U154
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2019
• Initial Date FDA Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2019
• 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
• Treatment: 1 IMPLANTED MITRACLIP
• Patient Outcome(s): Hospitalization; Required Intervention