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

Catalog Number SGC0301

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

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.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 this event.The reported patient effects of pericardial effusion and hypotension, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed to report the pericardial effusion.It was reported this was a mitraclip procedure to treat grade 4+ mixed mitral regurgitation (mr).When crossing the septum into the left atrium, the steerable guide catheter (sgc) was inadvertently advanced towards the left upper pulmonary vein.The procedure was continued and the mitraclip delivery system was advanced, the patient became bradycardic and hypotensive, requiring medication.A pericardial effusion was noted and pericardiocentesis was performed.The clip was deployed after pericardiocentesis and the symptoms resolved.The procedure was aborted, another clip may be implanted at a future date.Mr was reduced to 3-4.It is suspected the dilator/sgc caused the effusion when crossing the septum into the left atrium.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: 9318793
• MDR Text Key: 166936820
• Report Number: 2024168-2019-13550
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• 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: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Catalogue Number: SGC0301
• Device Lot Number: 90529U127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 57