MAUDE Adverse Event Report: ABBOTT VASCULAR G4 STEERABLE GUIDING CATHETER; CATHETER, STEERABLE

Catalog Number SGC0702

Device Problem Unintended Movement (3026)

Patient Problem Perforation (2001)

Event Date 05/18/2021

Event Type  Death  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The cds referenced in filed under a separate medwatch report number.

Event Description

This is filed to report the septum injury.It was reported this was a mitraclip procedure to treat mixed mitral regurgitation with an mr grade of 4.The steerable guide catheter (sgc) and mitraclip delivery system (cds) were inserted without problems.The septum ruptured approximately 3 cm, the sgc slipped further into the left atrium and the angle of the cds changed quickly into a pronounced aortic hugger and the cds dived more into the ventricle.An attempt was made to get the clip back to the left atrium, different maneuvers were used, including using the a-knob, but the clip appeared to be stuck to the anterior mitral leaflet (aml).The + knob and m knob were used, and the clip was freed from the aml.After some time, the clip no longer fully closed.It is possible tissue damage occurred leaving tissue caught in the clip preventing the clip from closing, however echo imaging was not clear at this moment to see if tissue was caught inside the clip.The clip was retracted to the tip of the sgc.One clip arm could not be moved into the scg.The decision was made to remove the sgc and the cds in this position through the vena cava inferior.The clip was pulled back approximately 10 cm before the puncture site in the right femoral vein, and the clip detached from the cds mandrel.The clip was no longer attached to the lock line or gripper line.A cut down was performed, and the clip was removed without problems, the septum was left untreated.No clips were implanted, mr remained at 4.No damage was noted to the sgc soft tip.Overnight the patient developed multiple organ failure including kidney failure and died on (b)(6)2021.Per the physician, the death was not related to or induced by the mitraclip devices.There was no additional information provided.

Manufacturer Narrative

This event was further reviewed by an abbott vascular medial affairs director and the reviewer stated that: ¿death was unrelated to the device but was related to the procedure since mr was left unchanged with a possible interatrial shunt due to septal partial rupture.There is no evidence of device issue and the septal rupture may have been a complication of the transseptal puncture possibly favored by technical issues.The reported perforation and death were an outcome of challenging anatomical condition/operational context.

Event Description

Subsequent to the previously filed reports, the following information was received: although the treating physician reported no relation between the death and the cds/sgc, abbott medical reviewer identified a possible relationship; thus the event is upgraded to a death report.

Manufacturer Narrative

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 resulted in this event.Additionally, a review of the complaint history identified no other incidents reported from this lot.The reported patient effect of cardiac perforation (perforation) and death as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated, and the reported unintended movement was an outcome of procedural circumstance/anatomical condition and is due to operational context.The reported perforation and unrelated death were an outcome of challenging anatomical condition/operational context.There is no indication of a product issue with respect to manufacture, design or labeling.

• Brand Name: G4 STEERABLE GUIDING CATHETER
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11967580
• MDR Text Key: 255165132
• Report Number: 2024168-2021-04823
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2022
• Device Catalogue Number: SGC0702
• Device Lot Number: 10206U429
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Death; Other