MAUDE Adverse Event Report: AV-TEMECULA-CT MITRACLIP SYSTEM STEERABLE GUIDE CATHETER

Catalog Number SGC0301

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

Patient Problem Atrial Perforation (2511)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effect of atrial septal defect (asd) (atrial perforation), as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Based on the information reviewed, the reported patient effect of atrial septal defect was likely a result of procedural conditions, as the steerable guiding catheter (sgc) is inserted through the septum in order to access the left atrium for positioning.The reported surgical procedure and prolonged hospitalization were a result of case specific circumstances as the patient underwent surgery the next day to treat the enlarged asd.There is no indication of a product quality issue with respect to manufacture, design or labeling.The clip delivery system referenced is filed under separate medwatch report.

Event Description

This report is submitted because, during the mitraclip procedure, the iatrogenic atrial septal defect enlarged.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.The steerable guiding catheter (sgc) and the clip delivery system (cds) were advanced to the right atrium.Due to challenging anatomy, there was difficulty grasping the mitral valve leaflets and multiple attempts were performed.When closing the clip to 100 degrees, the clip barely closed.Upon further closing the clip, mr was reduced to 1-2.However, once the clip was completely closed; mr returned to 4+.It is unknown why mr returned to 4+.Visualization was difficult.The clip was not deployed and the procedure was discontinued with no clips implanted.It was also noted that the iatrogenic atrial septal defect was enlarged by 4mm.On (b)(6) 2016, surgical mitral valve replacement and repair of the enlarged atrial septal defect was performed.The patient is stable.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Type of Device: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): MENLO PARK, CA REG# 3005070406; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6130087
• MDR Text Key: 60964787
• Report Number: 2024168-2016-08371
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648216824
• UDI-Public: (01)08717648216824(17)170914(10)60913U147
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/28/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2017
• Device Catalogue Number: SGC0301
• Device Lot Number: 60913U147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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
• Treatment: MITRACLIP CLIP DELIVERY SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 117