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

Model Number SGC0301

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

Patient Problem Atrial Perforation (2511)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

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 Description

This is filed to report the atrial septal defect (asd).It was reported that on (b)(6) 2017, one clip was implanted, reducing functional mitral regurgitation (mr) from 4+ to 2+.On (b)(6) 2020, the patient was hospitalized for treatment of the atrial septal defect (asd) with a right to left shunt.Prior to treating the asd, it was observed that mr had increased to 3-4 due to progression of disease.The clip remained secure on both leaflets and no injury was noted.One clip was implanted, reducing mr to 1.The asd was left untreated since mr reduction caused the right to left shunt to go left to right; therefore, no treatment was needed for the asd.The patient was fine.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effect of atrial septal defect as listed in the mitraclip system instructions for use, as a known possible complication associated with mitraclip procedures.Based on the available information, the reported atrial perforation was likely due to a combination of challenging anatomy and procedural conditions.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 10512275
• MDR Text Key: 206352196
• Report Number: 2024168-2020-07524
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: 08717648216824
• Combination Product (y/n): N
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2017
• Device Model Number: SGC0301
• Device Catalogue Number: SGC0301
• Device Lot Number: 61216U154
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED MITRACLIP(X2); IMPLANTED MITRACLIP(X2)
• Patient Outcome(s): Hospitalization
• Patient Age: 74 YR
• Patient Weight: 93