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 Respiratory Distress (2045); Atrial Perforation (2511)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 the atrial septal defect (asd).It was reported that a mitraclip procedure was performed to treat mitral regurgitation.One clip was implanted, reducing mr.At the end of august, an asd, with a left to right shunt was noted and a closure device was used as treatment.No additional information was provided.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: the mitraclip procedure was performed on (b)(6) 2019, reducing functional mitral regurgitation (mr) from 4 to 1.On (b)(6) 2019 a right to left shunt (atrial-septal defect/asd) with increased weight and oxygenation failure was confirmed by transthoracic echocardiogram (tte), and the patient was re-admitted to the hospital.On (b)(6) 2019, the asd was treated with a closure device.Following, the patient went to a rehabilitation facility.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 this event.The reported patient effects of atrial septal defect (asd) and respiratory distress, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported atrial septal defect (asd) and respiratory distress in this case appear to be related to patient morphology/pathology and/or user technique/procedural conditions; and unrelated to the device since there was no reported device issue/malfunction during the procedure.There is no indication of a product quality 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: 9168748
• MDR Text Key: 161927288
• Report Number: 2024168-2019-12434
• 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: 11/06/2019

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: 03/29/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90329U113
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention