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 to Remove (1528); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a de novo, 80% stenosed, moderately calcified and mildly tortuous vessel in the superficial femoral artery (sfa).The nose cone of the 6.0x150mm absolute pro self-expanding stent system (sess) got stuck at the proximal end of the stent during deployment.The physician tried to release the proximal end of the stent by rotating the wheel of the delivery system however, when they pulled out the stent delivery system, the partially deployed stent also got removed.There was no problem in the deployment mechanism.A 5.5x150mm supera stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned 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 incidents from this lot.It is possible that interaction with the 80% stenosed, moderately calcified and mildly tortuous anatomy resulted in restricting the shaft lumens from moving freely, thus preventing the stent from fully deploying; thus resulting in the reported activation/deployment failure and difficult to remove; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

Although the difficulties encountered appear to be related to procedural circumstances, on may 11th, 2022, abbott determined that a field safety notice (fsn) was required for the absolute pro ll peripheral self-expanding stent system (psess).Abbott has confirmed reports of mechanical locking, stent deployment and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent.To reduce occurrences of deployment failures and associated outcomes, abbott is notifying all users of the potential causes and risksna.

Event Description

It was reported that the procedure was to treat a de novo, 80% stenosed, moderately calcified and mildly tortuous vessel in the superficial femoral artery (sfa).The 6.0x150mm absolute pro self-expanding stent system (sess) nose cone of the stent got stuck at the proximal end of the stent during deployment.The physician tried to release the proximal end of the stent by rotating the wheel of the delivery system however, when they pulled out the stent delivery system, the partially deployed stent also got removed.There was no problem in the deployment mechanism.A 5.5x150mm supera stent was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.Subsequent to the initial report, on may 11th, 2022, abbott determined that a field safety notice was required for the absolute pro ll peripheral self-expanding stent system (psess).Abbott has confirmed reports of mechanical locking, stent deployment and partial stent deployment failures, resulting from unintended excessive force used to deploy the stent.To reduce occurrences of deployment failures and associated outcomes, abbott is notifying all users of the potential causes and risks; therefore, this event has been upgraded to reportable.

• 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: 13006083
• MDR Text Key: 283083109
• Report Number: 2024168-2021-11601
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

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: 1012015-150
• Device Lot Number: 1072361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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: COOK'S 035 AMPLATZ GUIDEWIRE