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

Catalog Number	SGC0101
Health Effect - Clinical Code	Thrombosis (2100)
Date of Event	01/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The steerable guide catheter 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 thrombosis, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.Although a conclusive cause for the reported patient effect of thrombosis and the relationship to the device, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
This is filed to report the thrombus, requiring intervention.It was reported that this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4.The transseptal puncture was performed and 8,000u of heparin was administered.The activated clotting time (act) was 266 seconds.An additional 2,000u of heparin was administered.The steerable guiding catheter (sgc) was advanced and then the clip delivery system (cds).While attempting to straddle the devices, a large thrombus was seen on the right atrial wall.An additional 3,000u of heparin was administered.The decision was made to continue to watch the thrombus.The cds was then advanced to the mitral valve, but the thrombus was then noted on the clip.The cds was removed with the thrombus clot and a ct scan was performed, which confirmed that the thrombus was removed from the patient anatomy.No additional thrombus was seen in the patient and the patient remained stable.The procedure was stopped with no clips implanted.The patient may be brought back at a later time for a new mitraclip procedure.No additional information was provided.

• Brand Name: MITRACLIP SYSTEM STEERABLE GUIDE CATHETER
• Common Device Name: STEERABLE GUIDE CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6305920
• Report Number: 2024168-2017-00970
• Device Sequence Number: 317598
• Product Code: DRA
• UDI-Device Identifier: 08717648195921
• UDI-Public: (01)08717648195921(17)170131(10)60108U122
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K161985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: SGC0101
• Device Lot Number: 60108U122
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 02/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MITRACLIP SYSTEM, CLIP DELIVERY SYSTEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 73