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 Anemia (1706); Hemorrhage/Bleeding (1888)

Event Date 01/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This report is filed due to post-procedure access site bleeding.It was reported that on (b)(6) 2017, the patient had a previous mitral valve procedure.One mitraclip was implanted without reported issues.The mitral regurgitation was reduced from grade 4 to 2.On (b)(6) 2019, a baseline echocardiogram was performed and mitral regurgitation was observed grade 4+.Reportedly, the previously implanted mitraclip remained stable and well seated.There was no tissue or leaflet injury suspected.On (b)(6) 2019, two mitraclips were implanted, without a device issue, reducing the mr to grade 1+.Post-procedure, bleeding from the puncture site was observed along with low hemoglobin.As treatment, one unit of packed red blood cells was provided; manual compression was held for 1 hour and a new compression bandage was applied for 2 hours.Right femoral angiography performed on (b)(6) 2019 showed normal results.The event resolved without sequela.No additional information was provided regarding this issue.

Manufacturer Narrative

Internal file number - (b)(4).There was no device malfunction and 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 hemorrhage is listed in the mitraclip system instructions for use is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported anemia and hemorrhage appear to be related to 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: 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: 8350510
• MDR Text Key: 136499638
• Report Number: 2024168-2019-01205
• 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: 03/21/2019

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: 10/03/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 81003U156
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 IMPLANTED MITRACLIPS; 3 IMPLANTED MITRACLIPS
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 80