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

Catalog Number UNK SGC01

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

Patient Problems Hypoxia (1918); Perforation (2001)

Event Date 11/27/2016

Event Type  Injury  

Manufacturer Narrative

Estimated date: (b)(6) 2016.The udi number is not known as the part and lot number were not provided.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Literature attachment: article title: haemodynamic and functional consequences of the iatrogenic atrial septal defect following mitraclip therapy.

Event Description

This is being filed to report the atrial septal defect (asd) and treatment.It was reported via literature that this was a mitraclip procedure to treat functional mitral regurgitation (mr).The mitraclip was successfully implanted.Following the procedure the patient experienced persistent hypoxaemia despite adequate end-expiratory values.Transesophageal echocardiography (tee) revealed a predominantly right-to-left shunt.The defect was closed with an amplatzer device after which the patient improved significantly.No additional information was provided.Details are listed in the attached article: "haemodynamic and functional consequences of the iatrogenic atrial septal defect following mitraclip therapy".

Manufacturer Narrative

D4: the udi# is unknown because the part and lot numbers were not provided.D4 and h4: the device expiration and manufacturing dates could not be provided as the device lot number was not provided and the device was not returned.The device was not returned for analysis.The lot history record (lhr) review was not performed because this incident was based on an article review and no device/lot information was provided.Based on the information reviewed, a cause for the reported perforation and hypoxia could not be confirmed.However; the reported patient effects of hypoxia and perforation as listed in the mitraclip instructions for use (ifu), are known possible complications associated with mitraclip procedures.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.Na.

• 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: 11727302
• MDR Text Key: 247384845
• Report Number: 2024168-2021-03533
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K112239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK SGC01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR