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

Catalog Number CDS0502

Device Problems Incomplete Coaptation (2507); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Respiratory Distress (2045); Tissue Damage (2104); Heart Failure (2206)

Event Date 12/14/2018

Event Type  Death  

Manufacturer Narrative

(b)(6): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Date estimated.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 heart failure and suspected single leaflet device attachment.It was reported that on (b)(6) 2018, the patient underwent a mitraclip procedure.On an unspecified date, the patient was hospitalized with symptoms of heart failure and a single leaflet device attachment (slda) was suspected.No additional information was provided.

Manufacturer Narrative

Patient codes: 2104 labeled 1802 labeled 2045 labeled.Device codes: 2993 labeled na.Internal file number - (b)(4).Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

Subsequent to the initial 30-day and follow-up #1 medwatch report, the following information was received: on (b)(6) 2018, one clip was implanted, reducing grade 4+ degenerative mitral regurgitation (mr) to grade 3+.On (b)(6) 2018, the patient began to experience respiratory distress.Transthoracic echocardiogram noted a tear on the posterior mitral leaflet and the clip was not detached as was previously reported.Medication was administered.On (b)(6) 2019, the patient died.There was no additional information provided.

Manufacturer Narrative

(b)(4).Correction: results code 114 - removed.Conclusions code - 4307 removed.The reported patient effects of death, respiratory failure (respiratory distress) and mitral valve injury (tissue damage), as listed in the mitraclip nt system instructions for use, are known possible complications associated with mitraclip procedures.This event was further reviewed by an abbott vascular medial affairs director, who concluded that the patient died on (b)(6) 2019 and no details are available about the circumstances and cause of death.There is no evidence that death was related to the device but it cannot be excluded that leaflet tear contributed to worsened clinical condition.Based on the information reviewed, a definitive cause for the reported respiratory distress, tissue damage, heart failure and death could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was provided: the mitraclip procedure was performed to treat grade 3 functional mitral regurgitation (mr).One clip was implanted, reducing mr to grade 2.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 records identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Additionally, a review of the complaint history did not indicate a lot-specific quality issue.The reported patient effect of heart failure as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.All available information was investigated and a definitive cause for the single leaflet device attachment (slda) could not be determined.The reported heart failure and hospitalization are cascading effects/procedural conditions of slda.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP SYSTEM CLIP DELIVERY SYSTEM NT
• Type of Device: MITRACLIP DELIVERY SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8248815
• MDR Text Key: 133090103
• Report Number: 2024168-2019-00354
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/03/2019

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: 06/20/2019
• Device Catalogue Number: CDS0502
• Device Lot Number: 80619U116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 04/17/2019; 04/30/2019; 05/28/2019
• Supplement Dates FDA Received: 04/23/2019; 05/28/2019; 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 46