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

Catalog Number	1007850-15
Medical Device Problem Codes	Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during preparation when pulling the stylet from the end of the 4.0 x 15 rx vision stent delivery system, slight resistance was met and the stent became dislodged, still remaining on the stylet.The device was not used and there was no patient involvement.Afterwards the physician manipulated and inflated the device on the table for troubleshooting purposes.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported difficult to remove could not be tested due to the condition of 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.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined that the reported difficulties appear 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 during preparation when pulling the stylet from the end of the delivery system, slight resistance was met and the stent became dislodged, still remaining on the stylet.The device was not used and there was no patient involvement.Afterwards the physician manipulated and inflated the device on the table for troubleshooting purposes.There were no adverse patient effects and no clinically significant delay in the procedure.Additional information was received confirming that the physician handled the device with bloodied gloves, the device never entered the patient, and the physician never troubleshooted/inflated the device once outside the anatomy.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: 8857678
• Report Number: 2024168-2019-10544
• Device Sequence Number: 14082270
• Product Code: MAF
• UDI-Device Identifier: 08717648050787
• UDI-Public: 08717648050787
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P020047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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: 1007850-15
• Device Lot Number: 7063041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1