MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP XTR DELIVERY SYSTEM; MITRACLIP DELIVERY SYSTEM

Catalog Number CDS0601-XTR

Device Problem Incomplete Coaptation (2507)

Patient Problems Death (1802); Mitral Regurgitation (1964); Tissue Damage (2104); Test Result (2695)

Event Date 04/16/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

This is filed for single leaflet device attachment (slda), leaflet tear and patient death.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.The xtr clip was implanted first, at the lateral anterior 2/posterior 2 (a2/p2) and an ntr was implanted at the medial a2/p2.The degenerative mitral regurgitation (mr) was reduced from grade 4+ to grade 2.On (b)(6) 2019, the patient was up walking and stated feeling good.However, an echocardiogram performed later that day noted that the xtr clip did not seem to be attached to the anterior leaflet (slda) and the mr had increased to grade 4+.On (b)(6) 2019, the patient was hypoxic, with poor pulmonary function.A transesophageal echocardiogram (tee) was performed and noted that a good segment of the anterior leaflet had been torn where it detached from the leaflet, and tissue remained in the clip.It was felt that a second procedure could not be performed, due to the amount of torn leaflet.The patient and family declined any additional intervention and the patient was treated with medical management.On (b)(6) 2019, the patient died.No additional information was provided.

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported patient effects of mitral regurgitation (mr), tissue damage and death 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 stated that death was not directly related to the device, but it is likely that the clip detachment contributed to worsening clinical status leading to death.All available information was investigated and the reported single leaflet device attachment (slda) appears to be related to patient morphology/pathology (friable leaflets).Mr and tissue damage were a cascading effect of the slda/procedural conditions.Hypoxia, with poor pulmonary function appears to be a result of the patients clinical condition; however, this cannot be definitively confirmed.A definitive cause for the death cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP XTR DELIVERY SYSTEM
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8601211
• MDR Text Key: 144744984
• Report Number: 2024168-2019-03751
• Device Sequence Number: 1
• Product Code: NKM
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

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: 11/14/2019
• Device Catalogue Number: CDS0601-XTR
• Device Lot Number: 81114U184
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 06/19/2019
• Supplement Dates FDA Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED NTR CLIP; IMPLANTED NTR CLIP
• Patient Outcome(s): Death
• Patient Age: 89 YR
• Patient Weight: 82