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

Catalog Number UNK ABSOLUTE PRO

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.It should be noted that the instructions for use (ifu), absolute pro vascular self-expanding stent system ifu states: ¿should unusual resistance be felt at any time, including resistance unlocking the handle or rotating the thumbwheel, during stent deployment, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Failure to follow these instructions could result in failure to deploy, difficulties with deployment, partial stent deployment or deployment in an unintended location.¿ in this case, it does not appear that the use of extra force to rotate the thumbwheel and deploy the stent contributed to the difficulty, as the stent was ultimately deployed.In addition, with the stent already partially deployed, the stent system would not be able to be removed together with the introducer sheath or guiding catheter as a single unit without causing damage to the stent.Based on the case information, a conclusive cause for the reported activation difficulty and resistance could not be determined.In this case, it is possible the anatomical conditions created enough friction to reduce activation, however this could not be confirmed because the device was not returned for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

During deployment of an unspecified absolute pro stent, resistance was met when turning the thumbwheel and the stent was partially deployed.Extra force had to be applied to successfully deploy the stent at the intended site.There were no adverse patient effects reported and no clinically significant delay reported.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 11389149
• MDR Text Key: 240317109
• Report Number: 2024168-2021-01526
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSOLUTE PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1