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

Model Number	1007848-18
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.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 to treat a lesion in the right coronary artery (rca) with heavy calcification.The 3.0x18mm rx vision coronary stent system was inserted but failed to cross the lesion.Therefore, the device was removed and again inserted.The device still failed to cross the lesion and was removed.Prior to inserting the device a third time, it was observed the stent was no longer on the catheter.It is unknown if the stent came off while in the anatomy.Ultrasound was performed but the stent was unable to be observed anywhere in the anatomy.However, the missing stent could also not be found outside the anatomy.Another device was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance could not be evaluated as the exact anatomical conditions encountered by the device during the procedure could not be replicated in the test laboratory.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.It was reported that the stent delivery system (sds) was removed from the anatomy and reinserted into the patient.It should be noted that the multi-link vision® coronary stent systems, domestic instructions for use (ifu), states: an unexpanded stent may be retracted into the guiding catheter one time only.Subsequent movement in and out through the distal end of the guiding catheter should not be performed as the stent may be damaged when retracting the undeployed stent back into the guiding catheter.Should any resistance be felt at any time during withdrawal of the coronary stent system, the entire system should be removed as a single unit.It is unknown if the ifu deviation contributed to the reported event.The investigation determined the reported failure to advance, stent dislodgement and the subsequent treatment including foreign body in patient appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.

• 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
• 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: 15103404
• Report Number: 2024168-2022-08156
• Device Sequence Number: 5255515
• Product Code: MAF
• UDI-Device Identifier: 08717648050633
• UDI-Public: 08717648050633
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

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: 12/31/2024
• Device Model Number: 1007848-18
• Device Catalogue Number: 1007848-18
• Device Lot Number: 2011043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 08/04/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDELINER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male