MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

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

Patient Problems Thrombosis (2100); Atrial Perforation (2511)

Event Date 03/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

This is filed for thrombus and atrial septal defect, requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.As the steerable guide catheter (sgc) crossed the transseptal puncture into the left atrium, a fluttering structure was noted, that was felt to be thrombus.Two clips were implanted and the mr was reduced to grade 1+.An atrial septal defect (asd) occluder was implanted as treatment of the asd.The event resolved on (b)(6) 2019.There was no additional information provided.

Manufacturer Narrative

Internal file number: (b)(4).Patient code 2511-labeled: removed.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 effect of thrombosis is listed in the mitraclip system instructions for use, as a known possible complication associated with mitraclip procedures.Based on the information reviewed, a conclusive cause for the thrombosis could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial 30-day medwatch report, additional information was provided, indicating that the atrial septal defect (asd) occluder was not implanted as treatment of an asd.The asd occluder was implanted as treatment of the thrombus, preventing possible translocation of the thrombus from the right atrium through the asd to the left atrium.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8542404
• MDR Text Key: 142876320
• Report Number: 2024168-2019-03212
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

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: 01/07/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90107U103
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIPS (X2)
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 70