MAUDE Adverse Event Report: AV-TEMECULA-CT ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM

Catalog Number	1003382-13
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/14/2017
Type of Reportable Event	Serious Injury
Additional 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 analysis.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The investigation determined the reported failure to advance, stent dislodgement, foreign body in patient and subsequent treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a 60% - 70% stenosed and heavily calcified lesion in the right coronary artery.Pre-dilatation was performed with 3.0x20mm and 3.5x15mm trek balloon dilatation catheters.A 5.0x13mm ultra rx stent delivery system (sds) was advanced; however, failed to cross due to anatomy.The sds was being removed without resistance when the stent dislodged.A cine confirmed the stent was floating in the femoral artery of the leg.An attempt to retrieve the stent with the delivery system was made but it was unsuccessful.The stent was left in free floating downward.The patient is reported to be ok and there was a 30% flow improvement.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

• Brand Name: ACS MULTI-LINK RX ULTRA CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6346718
• Report Number: 2024168-2017-01407
• Device Sequence Number: 1576786
• Product Code: MAF
• UDI-Device Identifier: 08717648035302
• UDI-Public: (01)08717648035302
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• 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): 02/21/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1003382-13
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR