MAUDE Adverse Event Report: ABBOTT VASCULAR STEERABLE GUIDE CATHETER; VALVE REPAIR

Catalog Number SGC0302

Device Problems Difficult to Insert (1316); Difficult to Advance (2920)

Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The steerable guide catheter was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The clip implanted during the index procedure was filed under a separate medwatch report # 2024168-2019-10852-00.The clip (81218u171) referenced is filed under a separate medwatch report number.

Event Description

This is being filed to report after the use of the steerable guide catheter, hematoma was noted at the puncture site which required additional medication and manual compression.It was reported that the initial mitraclip procedure was performed on (b)(6) 2019, to treat functional mitral regurgitation (mr).One clip (81006u179) was implanted, reducing mr to 1-2.On (b)(6) 2019, a second mitraclip procedure was performed to treat mr with a grade of 4+.The steerable guide catheter (sgc) was advanced through the right femoral vein and septal puncture from the index procedure.The first clip delivery system (cds 81218u171) was advanced and grasping was performed.Grasping of the posterior leaflet was weak; however, the clip was deployed on the medial side of the previously implanted clip with good mr reduction.After deployment, there was no change in mr.The sgc was removed and it was noted that the mr increased.Movement was noted on the posterior leaflet, and it was observed that the clip had torn the leaflet, but still remained attached to both leaflets.A new sgc (90329u148) was advanced through the left femoral vein, but was difficult to advance; therefore, the sgc was removed and advanced through the right groin.The right groin puncture was made slightly higher, and resistance was noted passing through the skin, but was successfully advanced.A second cds (90416u120) was advanced to the mitral valve.The anterior mitral leaflet was fixed by the implanted clip so that it was difficult grasp and it was difficult to see the long axis image due to the influence of the implanted clips.After the second cds insertion, the blood pressure dropped, and a hematoma was noted at the puncture site.Medication was given to control the hypotension and the patient recovered.The procedure continued while performing manual compression; however, grasping remained difficult; therefore, the clip was not implanted and the cds was removed.No further clips were attempted.The hematoma recovered the same day.One clip was implanted, and the mr remained at 4+.On (b)(6) 2019, there was no change to the patient condition and the heart failure did not improve; therefore, mitral valve replacement surgery was performed.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents reported from this lot.All available information was investigated and a conclusive cause for the reported failure to advance in this incident could not be determined.The reported difficult to insert appears to be related to procedural conditions.The hematoma and hypotension appears to be related to procedural conditions.The reported patient effects of hematoma and hypotension, as listed in the mitraclip system instructions for (ifu), are known possible complications associated with mitraclip procedures.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8941797
• MDR Text Key: 159518373
• Report Number: 2024168-2019-11287
• 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
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90329U148
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2 IMPLANTED MITRACLIPS
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 44