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

Catalog Number UNK CDS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Renal Failure (2041)

Event Date 01/01/2008

Event Type  Injury  

Event Description

This is filed to report that in a systematic review and meta-analysis study, where patients had undergone a mitraclip procedure, hypotension, acute kidney injury, and inflammation was reported.Although hypotension is not reportable, acute kidney injury and inflammation are considered serious injuries.This article is a systematic review and meta-analysis of the prognostic impact of pre- and post- procedural renal dysfunction on late all-cause mortality outcome following transcatheter edge-to-edge repair (teer) of the mitral valve using mitraclip (mc).The goal of this meta-analysis was to evaluate the impact of pre- and post- procedural renal dysfunction on late (=12 months) all-cause mortality following teer with mc.Electronic databases were systematically reviewed for studies evaluating mc outcome.Out of 2606 articles, 15 studies with 19,545 patients were included.Complications included late all-cause mortality.Pre-procedural renal dysfunction i.E. chronic kidney disease (ckd) was independently associated with higher late all-cause mortality.In addition, the development of post-procedural renal dysfunction was independently associated with higher late all-cause mortality after teer with mc.Pre- and post-procedural renal dysfunction is a strong independent predictor of late all-cause mortality following teer with mc and this should be considered during periprocedural planning for these patients.Specific patient information is documented as unknown.Details are listed in the attached article, titled, prognostic impact of pre- and post- procedural renal dysfunction on late all-cause mortality outcome following transcatheter edge-to-edge repair of the mitral valve: a systematic review and meta-analysis.No additional information was provided.

Manufacturer Narrative

The devices are not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Dates estimated.The udi number is ¿ni¿ as the catalog number was not provided.The additional patient effect(s) reported in the article are captured under a separate medwatch report.Attached article, titled, prognostic impact of pre- and post- procedural renal dysfunction on late all-cause mortality outcome following transcatheter edge-to-edge repair of the mitral valve: a systematic review and meta-analysis.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) review was not performed because no lot information was provided.Based on available information, the reported hypotension appears to be related to procedural circumstances.The reported renal failure appears to be a secondary effect of the hypotension and inflammatory response.The reported inflammation was likely due to procedural circumstances.The reported patient effects of renal failure, hypotension, hypersensitivity reaction (inflammatory response), as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported serious injury/ illness/ impairment was associated with no known treatment provided to the reported patient effects.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 14337905
• MDR Text Key: 291223021
• Report Number: 2024168-2022-05017
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK CDS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/09/2022
• Supplement Dates Manufacturer Received: 07/01/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male