MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER; VALVE REPAIR

Model Number UNK SGC03

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

Patient Problems Thrombosis (2100); Tissue Damage (2104); Foreign Body In Patient (2687)

Event Date 07/01/2014

Event Type  Injury  

Manufacturer Narrative

Article, titled: cerebral protection during mitraclip implantation.Estimated date.Exemption number: (b)(4)-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 i s not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The clip delivery system (cds) mentioned in the article is filed under a separate medwatch report number.Na.

Event Description

This is being filed to report foreign material, thrombosis, and prolonged hospitalization.It was reported through a research article identifying mitraclip and that may be related to the following: mitral stenosis, tissue damage, thrombosis, foreign material, embolism and prolonged hospitalization.The article also identified steerable guide catheters that may be related to the following: thrombosis, tissue damage, foreign material, prolonged hospitalization and peeling.Specific patient information is documented as unknown.Details are listed in the attached article, titled, cerebral protection during mitraclip implantation.No additional information was provided.

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 udi is unknown as the part and lot number was not provided.The device was not returned for evaluation.A review of the lot history record could not be performed as the lot information was not provided.The reported patient effects of tissue damage, foreign body in patient and thrombosis as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.A review of the lot history record could not be performed as the lot information was not provided.All available information was investigated and a definitive cause for the adverse events of tissue damage, foreign body in patient and thrombosis could not be determined as there is not enough information available.Hospitalization is a case specific circumstance.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: VALVE REPAIR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8920741
• MDR Text Key: 155202962
• Report Number: 2024168-2019-11052
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK SGC03
• Device Catalogue Number: UNK SGC03
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/31/2019
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization