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

Catalog Number SGC0301

Device Problem Difficult to Advance (2920)

Patient Problem Atrial Perforation (2511)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The second mitraclip clip delivery system is filed under a separate medwatch report number.

Event Description

This is filed to report the septal tear.It was reported that this was a mitraclip procedure to treat grade 4 degenerative mitral regurgitation (mr).The first mitraclip was advanced beneath the mitral valve.When it was pulled back to the left atrium, the height of the device was lower than it had been.The height was rechecked and it was suspected that there was a tear in the septum causing the lower height.Some adjustments were made to the position of the sgc (steerable guide catheter) to compensate for the tear in the septum and lost height.There was left to right shunting and the atrial septal defect was larger than expected, but no treatment was required.The procedure continued with deployment of the first mitraclip reducing mr to grade 2 to 3.When the second mitraclip was exiting the sgc into the left atrium, the patient went into ventricular fibrillation so the second undeployed clip was removed.The ventricular fibrillation was treated with defibrillation.The patient was stabilized but the procedure was aborted.Air embolism was suspected to be the cause of the ventricular fibrillation, but no air was visible.There were no issues using the mitraclip devices.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Review of the complaint history identified no similar incidents from this lot.The reported difficult to position the steerable guide catheter (sgc) appears to be due to the user technique/procedural circumstances as the unexpected movement/steering of the device appears to have influenced the reported adverse event.The atrial septal defect (atrial perforation) was a result of procedural circumstances as the sgc was observed to have lost height.The reported patient effect of atrial septal defect, 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 design, manufacturing, or labeling of the device.

• 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: 7928133
• MDR Text Key: 122444238
• Report Number: 2024168-2018-07618
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2018

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: 10/03/2018
• Device Catalogue Number: SGC0301
• Device Lot Number: 71002U246
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2018
• Initial Date FDA Received: 10/02/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TWO CLIP DELIVERY SYSTEMS
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 74