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

Catalog Number	1007821-23
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that before use, the stent of a 2.0 x 23 mm mini vision stent delivery system was found dislodged inside the protective sheath.Another 2.0 x 23 mm mini vision stent was used to successfully complete the procedure.There was no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001.A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.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 the reported stent dislodgement appears 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.
Event or Problem Description
It was reported that before use, the stent of a 2.0 x 23 mm mini vision stent delivery system was found dislodged inside the protective sheath.Another 2.0 x 23 mm mini vision stent was used to successfully complete the procedure.There was no patient involvement.No additional information was provided.

• Brand Name: 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: 8827479
• Report Number: 2024168-2019-10364
• Device Sequence Number: 2716829
• Product Code: MAF
• UDI-Device Identifier: 08717648049415
• UDI-Public: 08717648049415
• Combination Product (Y/N): N
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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: 05/31/2020
• Device Catalogue Number: 1007821-23
• Device Lot Number: 7062741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR