MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP G4 CLIP DELIVERY SYSTEM; MITRAL VALVE REPAIR DEVICES

Model Number CDS0701-XTW

Device Problems Difficult or Delayed Positioning (1157); Premature Activation (1484); Difficult to Remove (1528)

Patient Problems Anaphylactic Shock (1703); Atrial Fibrillation (1729); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Tachycardia (2095); Cardiogenic Shock (2262); Thrombosis/Thrombus (4440)

Event Date 03/25/2021

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The steerable guide catheter referenced is filed under separate medwatch report number.

Event Description

This is filed to report premature activation of the clip, atrial perforation, thrombus, hypotension, atrial fibrillation, tachycardia, cardiogenic shock, anaphylactic shock, requiring medical intervention.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with grade 4.The patient had a cath lab procedure one month prior in which the patient developed a severe rash after the procedure.Therefore, benadryl was administered prior to this procedure.Imaging was difficult due to the patient anatomy.The steerable guide catheter (sgc) was advanced and crossed the septum without issue.The clip delivery system (cds) was advanced to the mitral valve, but due to the low transseptal puncture, the clip was hitting the leaflets.Troubleshooting was performed, and the cds was re-positioned but the clip was still hitting the leaflets.It was decided not to use this xtw clip and switch to an ntw clip.The xtw clip was closed and when the cds was being withdrawn, the clip disconnected from the system and was affixed to the sgc soft tip.The sgc and the cds were removed together as one unit to avoid the clip from embolizing.However, when crossing the septum, there was some resistance due to the clip not being flushed inside the sgc and the atrial septal defect (asd) became bigger once the clip was at the groin, a cut down was performed to remove the clip.The clip was intact; however, a clot was noted on the clip and sgc tip.Thrombus was noted on the right side of the septum.The physician decided to abort the procedure as the patient¿s blood pressure started to drop and they had lost access.There were no clips implanted and mr remained at 4.Medication was administered and x-ray was performed to see what was causing the blood pressure to drop and nothing was observed.Then, the patient experienced atrial fibrillation (afib), ventricular tachycardia (v-tach) and cardiogenic shock.The physician suspected this occurred due to anaphylactic reaction to the heparin but was not certain.Cpr was performed for 22 minutes and the patient became slightly stable and was given blood transfusion to pump blood into the patient to raise the blood pressure.The patient was put on an intra-aortic balloon pump (iabp) for further stabilization, the patient did well, and blood pressure became stable.The patient was sent to intensive care unit (icu) and died 3 hours later.The patient was very sick prior to the mitraclip procedure.In the physician¿s opinion, the procedure or the mitraclip devices did not cause or contribute to the patient death.No additional information was provided.

Manufacturer Narrative

All available information was investigated, and the returned device analysis could not replicate the reported difficult to remove and premature activation as the clip was returned detached from the clip delivery system (cds) and in a plastic bag.The reported difficult positioning within anatomy could not be replicated in the testing environment as it was likely an outcome of procedural circumstances.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have resulted from this event.Additionally, a review of the complaint history identified no similar incidents from the reported lot.All available information was investigated, and the reported difficult positioning was due to low transseptal puncture/procedural circumstance.The reported poor image resolution was due to challenging patient anatomical condition.The reported difficult to remove was likely an outcome of user technique/procedural circumstances.The reported premature activation was cascading effect of the reported difficult to remove.The observed material split/cut (harness), material deformation of the harness, broken threaded stud and scratched threaded stud and actuator coupler are an outcome of procedural circumstances resulting from troubleshooting steps that were performed during the procedure post clip detachment from the cds.A conclusive cause for atrial perforation could not be determined in this complaint; however, the reported removal of foreign body was due to the reported premature activation.A conclusive cause for the reported thrombus could not be determined in this complaint and the reported hypotension was due to procedural circumstances.The reported required medication was a result of case specific circumstance.A conclusive cause for the reported atrial fibrillation, cardiogenic shock, anaphylactic shock, tachycardia and cardiogenic shock could not be determined in this complaint.The reported unexpected medical intervention (blood transfusion, cpr and iabp) were a result of case specific circumstances.The reported patient effect of surgical intervention was a result of case specific circumstance as minor cut down was performed to retrieve the clip from the groin.Lastly, the reported unrelated death was likely an outcome of procedural circumstance resulting from patient being very sick prior to mitraclip procedure.It should be noted that patient effect of perforation, hypotension, atrial fibrillation, tachycardia, cardiogenic shock, anaphylactic shock, thrombosis and death as listed in the mitraclip system instructions for use (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: MITRACLIP G4 CLIP DELIVERY SYSTEM
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11678770
• MDR Text Key: 245794799
• Report Number: 2024168-2021-03202
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 08717648231001
• UDI-Public: 08717648231001
• Combination Product (y/n): N
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

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: 04/07/2021
• Device Model Number: CDS0701-XTW
• Device Catalogue Number: CDS0701-XTW
• Device Lot Number: 00408U121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/16/2021
• Supplement Dates Manufacturer Received: 04/26/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STEERABLE GUIDE CATHETER; STEERABLE GUIDE CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 64