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

Catalog Number UNK ABSOLUTE PRO

Device Problems Break (1069); Stretched (1601); Difficult or Delayed Activation (2577); Mechanical Jam (2983)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/04/2021

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.The udi is unknown due to the part/lot number was not provided.

Event Description

It was reported that the procedure was to treat an unspecified artery.Upon deployment, the absolute pro self-expanding stent system (sess) got stuck midway through and the wheel stopped moving to enable the stent to be fully deployed.Only about 10-15 mm of the 120mm stent were deployed.The stent was ultimately deployed in the target lesion, however, it was noted to be broken and elongated.Another stent was used to deploy over the previously deployed absolute pro stent.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number was not provided.As there was no damage noted to the device during the inspection prior to use, it is possible that interaction with the anatomy resulted in restricting the shaft lumens from moving freely, thus preventing the thumbwheel from rotating and 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/deployment failure and mechanical jam difficulties cannot be determined.Interaction/manipulation of the device likely resulted in the reported broken and elongated deployed stent.The treatment appears to be related to the operational context of the procedure as another stent was used to deploy over the previously deployed absolute pro stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 12700845
• MDR Text Key: 278555114
• Report Number: 2024168-2021-09618
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Type of Report: Initial,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSOLUTE PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention