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

Model Number	1007849-12
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.It should be noted that the multi-link vision® coronary stent systems, domestic instructions for use (ifu), states: prior to using the multi-link vision rx or multi-link vision otw coronary stent system, carefully remove the system from the package and inspect for bends, kinks, and other damage.Verify that the stent does not extend beyond the radiopaque balloon markers.Do not use if any defects are noted.It is unknown if the ifu deviation contributed to the reported event.A conclusive cause for the reported stent dislodgement prior to use cannot be determined.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 the procedure was to treat a left anterior descending artery.A 3.5x12mm rx vision stent was prepped and then inserted into the patient.Once at the target lesion, the balloon was inflated and it was noted there was no stent on the balloon.The entire cath lab searched but could not find the stent.A scan was performed of the patient and the stent was not found inside the patient.It is assumed it dislodged during preparation as the stent was not found in the body.Another same size stent was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• 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: 11609453
• Report Number: 2024168-2021-02692
• Device Sequence Number: 14291763
• Product Code: MAF
• UDI-Device Identifier: 08717648050695
• UDI-Public: 08717648050695
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 04/02/2021

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: 11/30/2021
• Device Model Number: 1007849-12
• Device Catalogue Number: 1007849-12
• Device Lot Number: 8121741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1