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

Model Number	1007823-23
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
User facility medwatch report (mw5113174) received stating: voluntary report.Unable to deliver the stent to the lesion.Stent embolized to the rt.Femoral artery during removal of the stent.Radiologist into review the cine images surgeon into consult for stent removal from femoral artery site.Pt.Transferred to operating room for removal of the stent , stable, wife and son informed of the situation by physician.Abbot bare metal mini vision rx; 535 gtin: (b)(4).Fda safety report id# (b)(4).Additional information received from the site: the stent delivery system failed to cross due to the anatomy and could not be advanced past the left posterior descending artery (lpda)/distal circumflex (cx) origin of the main cx.When drawn back, the device did not go into the guide catheter.The proximal end of the stent seemed flared and the physician did not want to risk dislodgement.However, the stent dislodged and embolized to the right femoral artery.Vascular surgery was consulted and the patient had femoral endarterectomy.There was no adverse patient sequela.
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.User facility medwatch report #mw5113174.
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 other incidents.The reported difficulties appear to be related to the operational context of the procedure.The reported patient effect of embolism, as listed in the multi-link vision coronary stent system (css), instructions for use (ifu) is a known patient effect that may be associated with coronary stenting.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment, including removal of foreign body and surgical intervention, appear to be due to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15970801
• Report Number: 2024168-2022-12574
• Device Sequence Number: 4951846
• Product Code: MAF
• UDI-Device Identifier: 08717648049538
• UDI-Public: 08717648049538
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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 Expiration Date: 12/31/2023
• Device Model Number: 1007823-23
• Device Catalogue Number: 1007823-23
• Device Lot Number: 1010641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 56 KG