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

Catalog Number 1013016-150

Device Problems Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983); Activation Failure (3270)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Tissue Damage (2104)

Event Date 04/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 to treat a 100% stenosed, moderately tortuosity, moderately calcified, and chronic totally occluded lesion in the superficial femoral artery (sfa).The patient had pre-existing thrombus and thrombolysis was performed for two days.An 8.0x100mm absolute pro was successfully implanted in the external iliac artery.The sfa was pre-dilated with an 5.0x200mm armada 35 balloon catheter.The 6.0x150mm absolute pro ll self expanding stent system (sess) was advanced to the targeted lesion.After 2cm released, resistance was felt with the thumbwheel.Force was increased on the thumbwheel, but the stent did not release.The release handle was disassembled to try to manually pull the outer membrane of the stent to release the stent; this was unsuccessful.The stent was violently pulled out of the body.As a result of the violent pull out, approximately 1.5cm of the distal end of the stent broke in the common femoral artery.The sfa showed traces of endangium damage as a result of pulling the stent.A new 6.0x150mm absolute pro was deployed in the original lesion.A 6.0x80mm absolute pro stent and 6.0x100mm absolute pro stent were implanted at the proximal end of the sfa and distal of the first stent outside the ilium; the two stents were used to treat the damaged vessel and to crush the separated stent portion to the vessel wall.The operation was successfully completed and the patient is in good condition.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.Visual analysis was performed on the returned device.The reported deployment issue, thumbwheel jam and difficulty removing were unable to be confirmed due to the condition of the returned device.The stent separation was confirmed.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 complaints.The investigation was unable to determine a definitive cause for the difficulties.It may be possible that the distal shaft was bent or entrapped within the anatomy, preventing movement of the shaft lumens and causing the thumbwheel to lock up.The kinks noted sporadically at the proximal end of the sheath further suggest that the distal sheath was possibly kinked during deployment.The difficulty removing was likely the result of attempting remove the delivery system with the stent partially deployed.The stent separation likely occurred as the partially deployed stent was pulled out of the body with force.The reported tissue damage and additional treatment was due to case circumstances.It should be noted that the absolute pro ll instruction for use states: should unusual resistance be felt at any time during lesion or stricture access or delivery system removal, the introducer sheath / guiding catheter and stent system should be removed as a single unit.Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components.In this case, the partial stent deployment and inability to manually deploy the stent after the thumbwheel was no longer able to deploy the stent appear to be the cause for the series of event, including removing the delivery system with force.The reported patient effect of injury to artery (rupture, perforation, dissection) is listed in the absolute pro ll instruction for use as a known possible complication that may occur with use of the device.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

N/a.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported deployment issue, thumbwheel jam and difficulty removing were unable to be confirmed due to the condition of the returned device.The stent separation was confirmed.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 complaints.It should be noted that the absolute pro ll instruction for use states: should unusual resistance be felt at any time during lesion or stricture access or delivery system removal, the introducer sheath / guiding catheter and stent system should be removed as a single unit.Applying excessive force to the stent delivery system can potentially result in loss or damage to the stent and delivery system components.In this case, the partial stent deployment and inability to manually deploy the stent after the thumbwheel was no longer able to deploy the stent appear to be the cause for the series of event, including removing the delivery system with force.The investigation was unable to determine a definitive cause for the difficulties.It may be possible that the distal shaft was bent or entrapped within the anatomy, preventing movement of the shaft lumens and causing the thumbwheel to lock up.The kinks noted sporadically at the proximal end of the sheath further suggest that the distal shaft was possibly kinked over the aortic bifurcation during deployment.The difficulty removing was likely the result of attempting remove the delivery system with the stent partially deployed.The stent separation likely occurred as the partially deployed stent was pulled out of the body with force.The reported tissue damage and additional treatment was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H10: additional manufacturer narrative updated based on additional information in b5.

Event Description

Subsequent to the previously filed report, the following information was provided: the procedure was a cross over procedure.No additional information was provided.

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 risks.H6: investigation conclusions code 67 removed.

Event Description

Subsequent to the previous reports, 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: 10007849
• MDR Text Key: 189967850
• Report Number: 2024168-2020-03978
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 1013016-150
• Device Lot Number: 9042061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR