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

Catalog Number SGC0302

Device Problems Difficult or Delayed Positioning (1157); Difficult to Insert (1316); Deformation Due to Compressive Stress (2889)

Patient Problems Anemia (1706); Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Tissue Damage (2104)

Event Date 08/26/2020

Event Type  Death  

Manufacturer Narrative

The customer reported the device is returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The clip delivery system (cds) is filed under a separate medwatch report number.

Event Description

This is filed to report possible vein injury and death.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 3.The steerable guide catheter (sgc) was advanced.It was noted that there was resistance during insertion into the groin due to vessel tortuosity.The sgc was able to be advanced with resistance.It was observed under fluoroscopy that the sgc tip was bent down; therefore, the sgc was removed.The groin and abdomen were checked under echocardiogram and it was confirmed that there were no injuries.A new transseptal puncture was performed and the second sgc was advanced without issue.The clip delivery system (cds) was advanced, but was difficult to control and position due to the position of the sgc in a muscular portion of the valve; therefore, a second puncture was considered.The cds and sgc were retracted to the right atrium; however, the patient experienced tachycardia and hypotension, and the pacer was started repeatedly.The groin and pericardium were checked and no bleeding was visible.The patient was reanimated, but died.In the physicians opinion, the death was due to poor cardiac performance, repeated use of the pacer.Additionally, the physician suspected that there was a small hemorrhage in the groin due to the sgc bend, which the patient was not able to compensate for and it was noted that the patient was experiencing anemia.No additional information was provided.

Manufacturer Narrative

All available information was investigated and the reported kinked shaft was confirmed via return device analysis.The reported difficult to insert and difficult or delayed positioning associated with resistance during advancement of the steerable guide catheter (sgc) could not be replicated in a testing environment as they were related to operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history identified no other complaints from the lot.All available information was investigated and the reported difficult to insert and difficult or delayed positioning with anatomy associated with resistance during sgc advancement resulting in the bent/kinked tip appears to be related to patient conditions.The reported anemia, cardiac arrest, tissue damage, hemorrhage, hypotension, tachycardia and death appear to be related to patient and procedural circumstances.The patient effects of death, hemorrhage, tissue damage, hypotension, and cardiac arrest are listed in the mitraclip instructions for use (ifu) as known possible complications associated with mitraclip procedures.The additional therapy/non-surgical treatment was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10547248
• MDR Text Key: 207341714
• Report Number: 2024168-2020-07783
• 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: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2021
• Device Catalogue Number: SGC0302
• Device Lot Number: 00406U346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death