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

Catalog Number	1012538-40
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983); Insufficient Device Problem Information (3190); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an issue with the absolute pro self expanding stent system (sess).The stent had to be removed via a cut down.No additional information was provided.
Additional Manufacturer Narrative
B3: estimated date of event.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that there was an issue with the absolute pro self expanding stent system (sess).The stent had to be removed via a cut down.Subsequent to the initially filed report, it was reported that the procedure was to treat the proximal superficial femoral artery (sfa).Halfway through deployment of the absolute pro stent, the thumbwheel got stuck and would not advance.The stent was stuck in the sheath which pulled it out from the delivery catheter.The patient was hospitalized additional time.No additional information was provided.
Additional 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.As there was no damage noted to the device during the inspection prior to use, it is possible that the device was bent in the anatomy resulting in preventing the shaft lumens from moving freely resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent; however, this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported mechanical jam and the reported activation failure.During removal of the compromised device, interaction with the sheath resulted in the reported difficult to remove.The treatment appears to be related to the operational context of the procedure as reportedly the patient needed a cut down to remove the stent from the groin and the patient was hospitalized additional time.There is no indication of a product quality issue with respect to manufacture, design or labeling.E1: last name, title updated from unknown to dr.(b)(6).H6: medical device problem code 3190 removed and 1528, 3270, 2983 added.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: 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: 17878052
• Report Number: 2024168-2023-10899
• Device Sequence Number: 7666521
• Product Code: NIP
• UDI-Device Identifier: 08717648176289
• UDI-Public: 08717648176289
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 1012538-40
• Device Lot Number: 1091061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown