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

Model Number 1012538-100

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 05/24/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the distal superficial femoral artery (sfa) with moderate calcification and high at target lesion and moderate tortuosity.The 10.0x100mm absolute pro self-expanding stent system (sess) was advanced to the target lesion and the stent was attempted to be deployed; however, the thumbwheel of the sess was stuck.While attempting to remove the sess, the stent flowered approximately 2cm into the sheath.The sheath was pulled back; however the stent remained in the patient in the iliac bifurcation and partially in the target lesion.Then a second 10.0 x 40mm absolute pro sess was attempted to be advanced to treat the target lesion; however, it was noted that the first stent was deployed, partially in the introducer sheath.Therefore, the 10.0x40mm absolute pro failed to be inserted into the vessel, so the device was removed from the patient and the stent deployed outside the patient.The procedure was aborted since the lesion had been previously dilated.There was a delay in procedure resulting in increased anticoagulation time as well as the inability to treat the lesion.No additional information has been provided.

Manufacturer Narrative

The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other absolute pro self-expanding stent system (sess) is filed under a separate medwatch report number.

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 similar incidents from this lot.A cine was received and reviewed.It appears that the user did not follow the ifu instructions once the initial rotation of the thumbwheel stopped, became ¿stuck¿ and then removed the entire self expanding stent system (sess) and introducer sheath as a single unit.It should be noted the absolute pro vascular self-expanding stent system instructions for use (ifu) states: should unusual resistance be felt at any time, including resistance unlocking the handle or rotating the thumbwheel, during stent deployment, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Failure to follow these instructions could result in failure to deploy, difficulties with deployment, partial stent deployment or deployment in an unintended location.It does not appear that the deviation of the ifu caused/contributed to the reported activation failure including expansion failures and mechanical jam; however, the account reported that after the thumbwheel was stuck they attempted to remove the sess.It is possible that the distal shaft was bent in the moderately calcified and moderately torturous anatomy and/or interaction with other devices resulted in preventing the shaft lumens from moving freely resulting in the reported mechanical jam and the reported activation/deployment failure; however this cannot be confirmed.The investigation determined a conclusive cause for the reported activation failure including expansion failures and mechanical jam difficulties cannot be determined.The reported malposition is a result of the stent inadvertently deployed in the iliac bifurcation and partially in the target lesion.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initially filed report, the following information was received: the second absolute pro sess did not fully deploy outside the patient; although the stent did flower outside the patient.The second absolute pro sess was discarded by the facility.In addition it was reported that the patient was stable after the procedure was aborted.No additional information has been provided.

• Brand Name: ABSOLUTE PRO VASCULAR 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: 14700942
• MDR Text Key: 294131860
• Report Number: 2024168-2022-06430
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176319
• UDI-Public: 08717648176319
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

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: 04/30/2023
• Device Model Number: 1012538-100
• Device Catalogue Number: 1012538-100
• Device Lot Number: 0051361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male