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

Catalog Number SGC0302

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

Patient Problems Atrial Perforation (2511); Test Result (2695)

Event Date 01/15/2019

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 that would have contributed to this event.A conclusive cause for the reported difficulties, and the relationship to the product, if any, cannot be determined.The reported patient effect of atrial septal defect requiring intervention as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

This is filed on the steerable guide catheter to report the atrial septal defect requiring closure.It was reported that on (b)(6) 2019 this was a mitraclip procedure to treat grade 4 mixed etiology mitral regurgitation (mr).The mitral valve was accessed through the inter-atrial septum via the steerable guide catheter (sgc).Two mitraclips were implanted reducing mr grade to 1.The patient developed a right to left shunt resulting in hypoxia.The iatrogenic atrial septal defect was treated with an occluder device.The hypoxia resolved on (b)(6) 2019.The hospitalization was prolonged, but there was no adverse sequela.No additional information was provided.

Event Description

Subsequent to the previously filed report, additional information was received that the hypoxia and shunting was observed five days after the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction to the date of event.

• 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
• MDR Report Key: 8628122
• MDR Text Key: 145649584
• Report Number: 2024168-2019-03969
• 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: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/18/2019
• Device Catalogue Number: SGC0302
• Device Lot Number: 80817U130
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLIP DELIVERY SYSTEM; CLIP DELIVERY SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 51