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

Catalog Number 1012016-150

Device Problems Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.The reported activation/deployment failure was able to be confirmed.The stent was exposed for a length of 2mm.The reported mechanical jam was unable to be tested due to the condition of the returned device.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 inadvertent mishandling resulted in the noted crack on the stabilizer adjacent to the strain relief, thus restricting the shaft lumens from moving freely and thus preventing the thumbwheel from rotating resulting in the reported mechanical jam and the reported activation/deployment failure; however this cannot be confirmed.Manipulation of the device and thumbwheel likely resulted in the noted device damages (wrinkled sheath, smashed spool axel).There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure to treat a lesion in the right superior femoral artery (sfa) with heavy calcification and moderate tortuosity.A 7.0 x 150mm absolute pro self-expanding stent system (sess) was advanced to the target lesion.However, when attempting stent deployment, there was resistance when attempting to advance the thumbwheel.The thumbwheel would not turn and the stent could not be deployed; and therefore the sess was removed from the patient and the procedure was completed with an unspecified absolute pro sess.There was no adverse patient effects and no clinically significant delays in the procedure.No additional information was provided.The returned device analysis revealed that the stent was exposed for a length of 2mm.

Manufacturer Narrative

The device was returned for analysis.The reported activation/deployment failure was able to be confirmed.The reported mechanical jam was unable to be tested due to the condition of the returned device.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 inadvertent mishandling resulted in the noted crack on the stabilizer adjacent to the strain relief, thus restricting the shaft lumens from moving freely and thus preventing the thumbwheel from rotating resulting in the reported mechanical jam and the reported activation/deployment failure; however this cannot be confirmed.Manipulation of the device and thumbwheel likely resulted in the noted device damages (wrinkled sheath, smashed spool axel).There is no indication of a product quality issue with respect to manufacture, design or labeling.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 risks.H6: investigation conclusion code 4315 was removed.

Event Description

Subsequent to the original filing, 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.

• 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: 14045526
• MDR Text Key: 288820667
• Report Number: 2024168-2022-03698
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012016-150
• Device Lot Number: 1091561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: UNK
• Patient Sequence Number: 1