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); Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The 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 to report the access site fistula and pseudo-aneurysm.It was reported that 0n (b)(6) 2018, the patient underwent a mitraclip procedure, with implantation of one clip, reducing the functional mitral regurgitation (mr) from grade 3 to less than 1.An arteriovenous fistula and pseudoaneurysm developed at the femoral venous puncture site, leading to a drop in serum free hemoglobin.A transfusion of packed red blood cells was performed and a vascular endoprosthesis stent was deployed in the superficial right femoral artery to seal the leakages.The patient effect resolved on (b)(6) 2018.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effects of arterio-venous fistula and hemmorhage requiring transfusion as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported patient effect of fistula appears to be related to procedural conditions.The reported patient effect of hemmorhage appears to be a secondary effect of the fistula.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

(b)(4).The reported patient effect of psuedoaneurysm as listed in the mitraclip system instructions for use is a known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported patient effect of psuedoaneurysm appears to be related to procedural conditions.

• 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: 7535159
• MDR Text Key: 108978511
• Report Number: 2024168-2018-03824
• 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,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80117U102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN, CLOPIDOGRELIMPLANTED MITRACLIP (X1)
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 83