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

Model Number 1012534-80

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the right superficial femoral artery.A 6x80mm absolute pro self-expanding stent system (sess) had visibility issues, and the stent was deployed prior to reaching the target lesion despite not knowing the stent's location.The stent was nowhere to be found and could not be confirmed to be outside the patient anatomy.After removal, a bunched tip was noted on the distal end of the delivery catheter.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported difficulties were not confirmed as the stent was already deployed.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 revealed no other complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulties.It may be possible that anatomical conditions contributed to the visibility issue.As a result, the stent was reported to have deployed prior to reaching the target lesion, although the stent was unable to be found.Returned analysis noted that the approximately 4cm of the distal end of the sheath was separated and not returned and the sheath material at the separation was jagged.It is possible that the stent was partially deployed and during removal, the stent along with the separated portion of the distal sheath detached within the introducer sheath and therefore was unable to be located.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initially filed report, the following information was received: returned device analysis identified a separated portion of the sheath of the 6x80mm absolute pro self-expanding stent system (sess).Although this separation was not noted by the account, it was confirmed to not be in the patient anatomy.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9304887
• MDR Text Key: 166133570
• Report Number: 2024168-2019-13414
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176005
• UDI-Public: 08717648176005
• 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: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 1012534-80
• Device Catalogue Number: 1012534-80
• Device Lot Number: 9052261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 01/22/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 88