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

Model Number	1007848-12
Medical Device Problem Codes	Difficult to Remove (1528); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event, concomitant medical products: estimated date.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The bmw universal guide wire referenced is filed under a separate medwatch report number.
Event or Problem Description
A 3.00x12mm rx vision balloon-expandable stent system (bess) was returned in a bio bag without any information.There were no reported adverse patient effects.The returned device analysis identified that a bmw universal guide wire was returned frozen in the bess.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history was not performed because the failure mode was not specified.The investigation was unable to determine a conclusive cause for the reported difficulties as a failure mode was not reported.It was reported that a 3.00x12mm rx vision balloon-expandable stent system (bess) was returned in a bio bag without any information.There were no reported adverse patient effects.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 12198976
• Report Number: 2024168-2021-06253
• Device Sequence Number: 19750406
• Product Code: MAF
• UDI-Device Identifier: 08717648050619
• UDI-Public: 08717648050619
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: 05/31/2022
• Device Model Number: 1007848-12
• Device Catalogue Number: 1007848-12
• Device Lot Number: 9061441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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: GUIDE WIRE: BMW UNIVERSAL