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 Aneurysm (1708); Fistula (1862); Hematoma (1884); Pain (1994); Stenosis (2263)

Event Date 11/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The steerable guide catheter was discarded and there was no device malfunction reported.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 access site aneurysm, fistula, hematoma, and stenosis.It was reported that this was a mitraclip procedure to treat grade 3 mixed etiology mitral regurgitation (mr).On (b)(6) 2018 one mitraclip was implanted through the steerable guide catheter via the right groin access site, reducing mr grade to 1.On (b)(6) 2018 the patient had right groin pain.Duplex sonography found an aneurysm spurium arterio-venous fistula, hematoma, and stenosis of the femoral artery.Compression and compression bandages were performed for 24 hours; medication was administered, but the condition persisted.Surgical intervention for the condition was performed on (b)(6) 2018.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).Two steerable guide catheters (sgc) were used.Since it could not be confirmed which of these may have contributed to the reported patient effects, the lot history record review is provided for both lots.The results are as follows: lot 80621u255: manufacturing date: 21-june-2018, expiration date: 21-june-2019.Lot 80815u108: manufacturing date: 15-august-2018, expiration date: 15-august-2019.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issues to the reported lot that would have contributed to this event.Review of the complaint history revealed no evidence of a lot-specific product quality issue.The reported patient effects of aneurysm, fistula, hematoma, pain, stenosis and surgery are listed in the mitraclip system instructions for use, as known possible complications associated with mitraclip procedures.The reported patient effects appear to be related to patient morphology/pathology and/or user technique/procedural conditions.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: 8158379
• MDR Text Key: 130161072
• Report Number: 2024168-2018-09631
• 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: 01/29/2019

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 Catalogue Number: SGC0302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 72