MAUDE Adverse Event Report: ABBOTT VASCULAR BALLOON EXPANDABLE STENT; PERIPHERAL STENT DELIVERY SYSTEM

Model Number	1145250-28
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The additional bmw guide wire device referenced is filed under a separate medwatch report number.Na.
Event or Problem Description
It was reported that the procedure was treat a left anterior descending artery.A 2.5x28mm xience alpine was attempted to advance over the 014 balance middleweight hydro guide wire; however, it became stuck.Both devices were simply removed as one unit.Another unspecified stent and guide wire were used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
No investigation required.Subsequent to filing the initial report, the following clarification was received: the 2.5x28mm xience alpine was the device used to successfully complete the procedure and not the device that became stuck on the bmw guide wire.The device that became stuck on the bmw guide wire was a non-abbott stent.B5: additional information received clarifying the complaint device.D1: xience alpine otw everolimus eluting coronary stent system was removed and balloon expandable stent was added.D2: drug eluting coronary stent delivery system was removed and peripheral stent delivery system was added.D4: all section was removed and updated to unknown and unknown stent.D10: bmw guide wire removed.G1: manufacturing site name, address, city, country, e-mail removed.G4: nda#, pma/510k, combination product updated.H3: updated from yes to no.H6: codes 2920 and 1528 were removed and 3189 was added.
Event or Problem Description
It was reported that the procedure was treat a left anterior descending artery.A 2.5x28mm xience alpine was attempted to advance over the 014 balance middleweight hydro guide wire; however, it became stuck.Both devices were simply removed as one unit.Another unspecified stent and guide wire were used to successfully complete the procedure.There was no adverse patient effects and no clinically significant delay.Subsequent to filing the initial report, the following clarification was received: the 2.5x28mm xience alpine was the device used to successfully complete the procedure and not the device that became stuck on the bmw guide wire.The device that became stuck on the bmw guide wire was a non-abbott stent.No additional information was provided.

• Brand Name: BALLOON EXPANDABLE STENT
• Common Device Name: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11178874
• Report Number: 2024168-2021-00488
• Device Sequence Number: 2994507
• Product Code: NIQ
• UDI-Device Identifier: 08717648199912
• UDI-Public: 08717648199912
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• 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,Followup
• Report Date (Section B): 02/25/2021

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: 08/25/2022
• Device Model Number: 1145250-28
• Device Catalogue Number: UNKNOWN STENT
• Device Lot Number: 9081941
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/25/2021
• 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: 014 BALANCE MIDDLEWEIGHT HYDRO GUIDE WIRE.