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

Model Number	1007848-28
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a target lesion in the left tibial artery.A non-abbott guide wire was advanced into the patient anatomy and other devices were advanced over the guide wire without issue.The 3.0 x 28 mm vision stent delivery system (sds) was inserted onto the guide wire.During advancement on the guide wire, the physician noted the guide wire was gritty and sticky, and resistance was noted advancing the sds.The decision was made to remove the sds.Resistance was noted during removal and the tip of the sds separated.As the device had not entered the patient anatomy, the sds and the separated tip were easily removed from the guide wire.There was no adverse patient effect.The physician wiped the guide wire.The procedure was continued with implant of two additional vision stents using the same guide wire.There were no adverse patient effects and no clinically significant delay.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 that the reported difficulties appear 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.

• 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: 11402198
• Report Number: 2024168-2021-01646
• Device Sequence Number: 3631974
• Product Code: MAF
• UDI-Device Identifier: 08717648050657
• UDI-Public: 08717648050657
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 03/31/2022
• Device Model Number: 1007848-28
• Device Catalogue Number: 1007848-28
• Device Lot Number: 9040941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/24/2021
• 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: MIRACLE BROS GUIDE WIRE
• Patient Age: 72 YR
• Patient Weight: 63