MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM; VALVE REPAIR

Catalog Number	CDS0501
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Mitral Regurgitation (1964); Tissue Damage (2104)
Date of Event	07/17/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
B2: date of death - estimated.D7: date of explant - estimated.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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.
Event or Problem Description
This is filed to report the patient death.It was reported that the initial mitraclip procedure was performed on (b)(6) 2019 to treat mitral regurgitation (mr) with a grade of 4+.One clip was implanted successfully reducing mr to 1+.On (b)(6) 2019, the patient presented with dyspnea and pulmonary hypertension.Echocardiogram was performed showing the clip detached from the posterior leaflet and remained attached to the anterior leaflet (single leaflet device attachment/slda).Tissue damage was noted and mr increased to 4+.On an unspecified date, mitral valve replacement was performed.The patient was not able to recover from the systemic inflammatory response of cardiac surgery and died 24 hours after the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 contributed to this event.Additionally, a review of the complaint history did not identify any similar incidents.It should be noted that the reported patient effects of mitral valve injury (tissue damage), mitral regurgitation, hypertension, and death as listed in the mitraclip system instructions for use (ifu) are known possible complications associated with mitraclip procedures.This event was further reviewed by an abbott vascular medial affairs director.The reviewer concluded, death was a complication of surgery and was unrelated to the device.However, the need for surgery was related to the clip detachment associated with tissue damage.All available information was investigated and the definitive cause for reported single leaflet device attachment/slda resulting in tissue damage and mitral regurgitation could not be determined.Based on the information reviewed the tissue damage and mitral regurgitation were due to slda.The investigation was unable to determine a definitive cause for the patient effect of hypertension and shortness of breath.Death was due to patient¿s health complications.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Subsequent to the initial 30-day medwatch report, the following information was provided: mitral valve replacement was performed on (b)(6) 2019.The patient died on (b)(6) 2019.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Common Device Name: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8942399
• Report Number: 2024168-2019-11302
• Device Sequence Number: 2041328
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 81205U291
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/04/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR
• Patient Weight: 65