MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0302

Device Problem Failure to Advance (2524)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Perforation (2001); Heart Failure (2206)

Event Date 04/09/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

This is filed to report the patient death.It was reported this was a mitraclip procedure to treat grade 4, functional mitral regurgitation (mr).Resistance was felt, with the anatomy, while advancing the steerable guide catheter (sgc) after advancing approximately 20-30cm.A venous rupture was noted, and the procedure was aborted.No clips were implanted.Mr remained at 4.The patient was sent to surgery for treatment of the perforation.The perforation was repaired and bleeding stopped.The patient was taken to the intensive care unit for recovery; however, due to cardiac failure, the patient died.Per the physician, the sgc caused the damage to the venous vessel and bleeding.Due to treatment with a coagulant for the bleeding, it was suspected that stent thrombosis occurred and may have caused the cardiac failure.No additional information was provided.

Manufacturer Narrative

Patient codes: 2206 labeled.Internal file number - (b)(4).If follow-up, what type: correction: mfr site: contact name.The device was not returned for evaluation.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 effects of cardiac arrest, death, hemorrhage (hemorrhage requiring transfusion) and perforation (cardiac perforation) as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.This event was further reviewed by an abbott vascular medical affairs director, who concluded that the death was not directly related to the device, but the procedural complication triggered a cascade of events that led to the fatal outcome.Based on the information reviewed, failure to advance the steerable guide catheter (sgc) appears to be related to patient morphology/pathology.A definitive cause for reported perforation, hemorrhage and heart failure cannot be determined.Death was a cascading effect of the cardiac arrest/failure.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: 8566278
• MDR Text Key: 143599963
• Report Number: 2024168-2019-03423
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

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: 01/05/2020
• Device Catalogue Number: SGC0302
• Device Lot Number: 90104U203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/30/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death