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

Catalog Number 1013015-150

Device Problems Entrapment of Device (1212); Mechanical Jam (2983); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

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 an intact stenosis of the right superficial femoral artery (sfa).An armada 35 percutaneous transluminal angioplasty (pta) catheter was used to dilate the stenotic vessel and then a 5.0x120 mm absolute pro stent was implanted in the distal sfa.A 5.0x150 mm absolute pro stent was planned to be implanted along the 5.0x120 mm absolute pro stent and overlap the stents by 1 cm.However, after 1/4 release of the 5.0x150 mm absolute pro stent, the pulley could not be rotated and the stent could not be released at all despite multiple attempts.The handle of the stent was disassembled but the stent could still not be released.The vessel was then cut and the stent was cut to be removed.The delivery sheath was cut and the rest of the delivery sheath was removed and the vessel was sutured.Next, a 5.0x80 mm absolute pro stent was successfully released at the overlapping position as well as a 5.0x100 and 6.0x120 mm absolute pro stents as this was a long lesion.A 6.0x150 mm armada 35 pta catheter was attempted to be used to post-dilatation and was advanced through the crossover sheath to the superficial opening but the balloon could not be advanced to the stent for post dilatation for an unspecified reason.After withdrawal of the balloon, angiography was performed and blood flow was significantly improved and the procedure was completed.There were no reported adverse patient sequela.No additional information was provided.

Event Description

Additional information provided indicates that the device was used with a 0.035 guide wire.No additional information was provided.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported partial deployment and handle disassembled was confirmed.The entrapment of the device was unable to be confirmed as it was based on procedural circumstances.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 indication of a lot specific product quality issue.The investigation was unable to determine a cause for the reported deployment issue and mechanical jam of the thumbwheel.Potential factors for difficulty deploying the stent due to thumbwheel resistance include, but are not limited to, manufacturing, anatomical conditions, use of an undersized diameter guide wire or deployment technique and/or damage to the device deployment mechanisms (handle components/shaft lumens).In this case, it may be possible that the distal shaft was bent or restricted in the anatomy (possibly at the aortic bifurcation) preventing the shaft lumens from moving freely and preventing the thumbwheel from rotating; however, this could not be confirmed.The additional treatment was related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported partial deployment and handle disassembled was confirmed.The entrapment of the device was unable to be confirmed as it was based on procedural circumstances.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 indication of a lot specific product quality issue.The investigation was unable to determine a cause for the reported deployment issue and mechanical jam of the thumbwheel.Potential factors for difficulty deploying the stent due to thumbwheel resistance include, but are not limited to, manufacturing, anatomical conditions, use of an undersized diameter guide wire or deployment technique and/or damage to the device deployment mechanisms (handle components/shaft lumens).In this case, it may be possible that the distal shaft was bent or restricted in the anatomy (possibly at the aortic bifurcation) preventing the shaft lumens from moving freely and preventing the thumbwheel from rotating; however, this could not be confirmed.The additional treatment was related to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.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 4315 removed; 4307 added.

Event Description

It was reported that the procedure was to treat an intact stenosis of the right superficial femoral artery (sfa).An armada 35 percutaneous transluminal angioplasty (pta) catheter was used to dilate the stenotic vessel and then a 5.0x120 mm absolute pro stent was implanted in the distal sfa.A 5.0x150 mm absolute pro stent was planned to be implanted along the 5.0x120 mm absolute pro stent and overlap the stents by 1 cm.However, after 1/4 release of the 5.0x150 mm absolute pro stent, the pulley could not be rotated and the stent could not be released at all despite multiple attempts.The handle of the stent was disassembled but the stent could still not be released.The vessel was then cut and the stent was cut to be removed.The delivery sheath was cut and the rest of the delivery sheath was removed and the vessel was sutured.Next, a 5.0x80 mm absolute pro stent was successfully released at the overlapping position as well as a 5.0x100 and 6.0x120 mm absolute pro stents as this was a long lesion.A 6.0x150 mm armada 35 pta catheter was attempted to be used to post-dilatation and was advanced through the crossover sheath to the superficial opening but the balloon could not be advanced to the stent for post dilatation for an unspecified reason.After withdrawal of the balloon, angiography was performed and blood flow was significantly improved and the procedure was completed.There were no reported adverse patient sequela.Additional information provided indicates that the device was used with a 0.035 guide wire.No additional information was provided.Subsequent to the original 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.

• 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: 10369202
• MDR Text Key: 201857249
• Report Number: 2024168-2020-06540
• 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
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 1013015-150
• Device Lot Number: 0012361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 09/17/2020; 05/11/2022
• Supplement Dates FDA Received: 10/09/2020; 06/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2020
• 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: 0.035 GUIDE WIRE; 5.0X120 MM ABSOLUTE PRO
• Patient Outcome(s): Required Intervention