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 Fistula (1862); Atrial Perforation (2511)

Event Date 11/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

This report is filed due to an atrial septal defect and arteriovenous fistula.It was reported that the patient presented with degenerative mitral regurgitation (mr) grade 3+, with a bi-leaflet prolapse (a3p3) and anterior leaflet flail.Two mitraclips were implanted without a device issue, reducing the mr to grade 1+.An atrial septal defect (asd) was treated with an asd closure device.Post-procedure, a groin arteriovenous fistula was noted.Imaging was performed and conservative treatment was provided with compressions.Prolonged hospitalization was required.The event resolved and the patient was discharged from the hospital on (b)(6) 2018.No additional information was provided regarding this issue.

Event Description

Subsequent to the previous medwatch report, the additional information was received: on (b)(6) 2018, a mitraclip procedure was attempted but was stopped since a left atrial thrombus was suspected.There was no mitraclip device in the anatomy during this time.Imaging was performed to rule out ischemia or vascular occlusion.No evidence was found.On (b)(6) 2018, a mitraclip procedure was performed, placing two clips without a device issue.An atrial septal defect (asd) was treated with an asd closure device.

Manufacturer Narrative

Internal file number - (b)(4).Device status changed from yes, returning to no, not returned.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.In this case, there was no reported device malfunction associated with the steerable guide catheter (sgc).The reported patient effect fistula (arterio-venous fistula), atrial perforation (cardiac perforation) 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.

• 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: 8347565
• MDR Text Key: 136488905
• Report Number: 2024168-2019-01180
• 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: foreign,health professional,s
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80515U151
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM (X2)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 129