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

Catalog Number	1003382-18
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2017
Type of Reportable Event	Malfunction
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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported failure to advance and stent dislodgement appear to be related to circumstances of the procedure and 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 during a procedure of the non-tortuous, non-calcified, thrombosed, right coronary artery (rca), the 5.0 x 18 mm ultra stent delivery system (sds) was advanced in a non-abbott guideliner, but could not cross the lesion due to the anatomy.During removal of the sds from the anatomy, the stent implant dislodged while in the tuohy rotating hemostasis valve (rhv), outside the anatomy.A non-abbott stent system was used to complete the procedure.There was no reported adverse patient sequela or a clinically significant delay in the procedure.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: 6726157
• Report Number: 2024168-2017-06024
• Device Sequence Number: 10953144
• Product Code: MAF
• UDI-Device Identifier: 08717648035319
• UDI-Public: 08717648035319
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 1003382-18
• Device Lot Number: 6092241
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 91