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

Catalog Number	1007847-18
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.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 performed to treat a lesion in the right coronary artery with heavy calcification and mild tortuosity.An unspecified guide wire was advanced to the target lesion.Then a 2.75 x 18 mm vision stent delivery system (sds) was advancing over the guide wire; however, resistance met with the guide wire.Therefore, the sds retracted back with resistance when the tip became separated outside the patient¿s anatomy.The detached tip and the remainder of the sds was removed from the guide wire.Another 2.75 x 18 mm vision sds was advanced with the same guide wire.The target lesion was successfully treated.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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.A visual and dimensional inspection was performed on the returned device.The reported material separation was confirmed.The reported difficult to advance and 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 other incidents.The investigation determined that the reported tip separation appears to be related to circumstances of the procedure.A conclusive cause for the reported difficult to advance/position and difficult to remove (guide wire resistance) could not be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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: 9246792
• Report Number: 2024168-2019-12990
• Device Sequence Number: 2054897
• Product Code: MAF
• UDI-Device Identifier: 08717648050572
• UDI-Public: 08717648050572
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/19/2019

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: 06/30/2020
• Device Catalogue Number: 1007847-18
• Device Lot Number: 7072541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1