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

Catalog Number 1012015-150

Device Problems Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2020

Event Type  Injury  

Manufacturer Narrative

The product was not returned to abbott vascular for analysis.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 similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.It may be possible that the distal sheath was entrapped or restricted within the lesion causing resistance between the shaft lumens and preventing the thumbwheel from rotating and as a result the physician decided to open the device in order to deploy the stent; however, without having the device to examine, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a superficial femoral artery (femoral to femoral crossover).A 6x150mm absolute pro ll stent was advanced to the lesion.The stent was partially deployed when the thumbwheel became stuck and stopped deploying the stent.The physician decided to break the handle tip and manually pull the catheter back for successful stent placement.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• Brand Name: ABSOLUTE PRO LL 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: 11096432
• MDR Text Key: 224426040
• Report Number: 2024168-2020-11016
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 1012015-150
• Device Lot Number: 8041862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2018
• 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
• Treatment: TERUMO GW ,0.035
• Patient Outcome(s): Required Intervention