MAUDE Adverse Event Report: ABBOTT VASCULAR MULTI-LINK RX VISION CORONARY STENT SYSTEM; CORONARY STENT DELIVERY SYSTEM

Model Number	1007850-18
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified de novo lesion in the mid left anterior descending coronary artery (mlad).During advancement of the rx vision stent delivery system (sds), the stent dislodged prior to entering the tuohy valve; however, this was not noted until after the balloon was inflated at the lesion.There was no reported adverse patient effect or a clinically significant delay in the procedure.Another rx vision was successfully implanted to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
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 identified no similar incidents from this lot.The investigation determined the reported stent dislodgement 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.D10, h3: device not available for evaluation.

• Brand Name: MULTI-LINK RX VISION CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10589731
• Report Number: 2024168-2020-08024
• Device Sequence Number: 3028149
• Product Code: MAF
• UDI-Device Identifier: 08717648050794
• UDI-Public: 08717648050794
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2020

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: 12/31/2020
• Device Model Number: 1007850-18
• Device Catalogue Number: 1007850-18
• Device Lot Number: 8010441
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1