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

Model Number 1012536-30

Device Problems Entrapment of Device (1212); Malposition of Device (2616); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Visual and functional analysis was performed on the returned device.The reported malposition, migration and entrapment in the vessel were unable to be confirmed/tested as the stent had already been fully deployed and was not returned.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 reported from this lot.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the distal sheath was restricted or entrapped within the anatomy causing the stent to "jump" during deployment due to built-up tension within the shaft lumens of the delivery system resulting in a spring like release of the stent; however, this could not be confirmed.The migration may have occurred during the attempt to snare the stent resulting in the stent migrating into the left pulmonary.The additional treatment, foreign body in patient and delay in procedure appear to be due to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a left av fistula.An absolute pro self-expanding stent system (sess) was advanced to the lesion; however, upon turning the wheel to deploy the stent, the stent flowered and jumped out.An attempt was made to snare the stent, but the stent migrated into the left pulmonary and became lodged there.Another same sized absolute stent was used to successfully treat the lesion.The patient will be transferred to surgery to remove the foreign body in the left pulmonary.No additional information was 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: 10621532
• MDR Text Key: 209637072
• Report Number: 2024168-2020-08229
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08717648176135
• UDI-Public: 08717648176135
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1012536-30
• Device Catalogue Number: 1012536-30
• Device Lot Number: 0072861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2020
• 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: .035 HYDROSTEER WIRE
• Patient Outcome(s): Required Intervention