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

Catalog Number	CDS0501
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Remove (1528)
Health Effect - Clinical Codes	Mitral Regurgitation (1964); Tissue Damage (2104)
Date of Event	09/10/2019
Type of Reportable Event	Serious Injury
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 the reported event.Additionally, a review of the complaint history did not indicate a lot-specific product issue.It should be noted that while the mitral regurgitation (mr) ultimately remained unchanged, the reported patient effects of worsening mr and chordal rupture (tissue damage) as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.All available information was investigated, and the reported positioning failure and difficult to remove from the anatomy appears to be related to patient morphology/pathology (calcified valve and flailed leaflets).The reported tissue damage resulting in unchanged mr was likely a result of clip becoming caught in the chordae and therefore related to procedural circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
Event or Problem Description
This is filed to report clip difficult removal and tissue damage.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The first two clips were implanted successfully.To further reduce mr a third clip was advanced, the clip got caught on chordae.The clip was freed; however, a chordae rupture occurred, and mr returned to 4.Grasping attempts were made, there was loss of leaflet capture, the anterior leaflet would not stay captured.The clip was not implanted and was removed without further issue.No additional treatment is planned for the patient.No additional information was provided.

• 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: 9132066
• Report Number: 2024168-2019-12189
• Device Sequence Number: 14031694
• Product Code: NKM
• UDI-Device Identifier: 08717648216800
• UDI-Public: 08717648216800
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2019

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: 09/13/2019
• Device Catalogue Number: CDS0501
• Device Lot Number: 80911U104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPLANTED MITRACLIP (X2); STEERABLE GUIDE CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 83 YR
• Patient Weight: 92