MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

Model Number 1012534-20

Device Problems Break (1069); Difficult to Insert (1316); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the absolute pro stent delivery system was unable to be inserted/back loaded unto the unspecified guide wire.A bending was then observed on the absolute pro catheter.The exact location of the bend was not specified by the account.The device was set aside and not used.There was no adverse patient effect or other device issues reported.Another device was successfully used in replacement.No additional information was provided regarding this issue.Subsequently the device was received at abbott vascular and preliminary analysis revealed multiple tears on the jacket at the location of the kink.The inner braiding material was separated (not in two separate pieces) within the jacket at the location of the kink.

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported difficulty advancing the guide wire 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 other complaints.The investigation determined that the reported difficulties were likely related to procedural circumstances.It is likely that the difficulty encountered advancing the guide wire was the result of the severe kink/tear noted on the returned unit.Although a cause for the damage could not be determined, it may be possible that inadvertent mishandling during removal from the packaging or during preparation caused shaft to kink preventing the guide wire from advancing.Additional handling and the continued attempt to advance the guide wire with the shaft kinked may have caused the shaft to tear preventing any further advancement of the guide wire.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: ABSOLUTE PRO VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11072428
• MDR Text Key: 223618500
• Report Number: 2024168-2020-10771
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648175961
• UDI-Public: 08717648175961
• Combination Product (y/n): N
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 1012534-20
• Device Catalogue Number: 1012534-20
• Device Lot Number: 8090561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR