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); Difficult to Remove (1528); Stretched (1601); Material Deformation (2976); Activation Failure (3270); Migration (4003)

Patient Problems Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)

Event Date 01/16/2024

Event Type  Injury  

Event Description

It was reported that the procedure was performed to treat a heavily calcified target lesion in the superficial femoral artery (sfa), with intended stenting locations in the distal, mid and proximal sfa.The patient anatomy included high-grade stenosis in the ipsilateral sfa due to a sclerosed unspecified vascular plug in the distal sfa.On the contralateral side, there was vascular calcification in the pelvic inlet without limitation of wire probing.A 6french crossover sheath was used and the first absolute pro self-expanding stent system (sess) was advanced to the distal sfa.Deployment was initiated; however, the stent only partially deployed, although there was no reported issue with the thumbwheel, and was caught on the vascular plug.During removal of the delivery system, the stent fully deployed, as it remained caught on the vascular plug.The stent was deemed not possible to retrieve and remains in the patient anatomy.The second absolute pro sess was advanced to the target lesion and deployment was initiated; however, during deployment, difficulty was noted with the final release and a complete loss of mesh structure occurred.The stent fissured [break] and stretched three times its length.The stent migrated and became embedded in the pelvic circulation, completely outside the target lesion.The stent was unable to be retrieved and occluded the vessel.Balloon angioplasty was performed as treatment of the occlusion.A third absolute pro sess was advanced to the target lesion; however, the stent could not be deployed, although there was no reported issue with the thumbwheel.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

D4: the udi number is not known as the part and lot number were not provided.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional absolute pro device referenced in b5 is filed under separate medwatch report number.

Manufacturer Narrative

The device was not returned for analysis.Electronic lot history record (elhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.The reported patient effects of occlusion and intervention due to stent migration, unintentional placement of stent, partial stent deployment, stretched and/or damaged stents are listed in the absolute pro.035 peripheral self-expanding stent system instructions for use as adverse events that may be associated with the use of a stent in peripheral arteries and/or biliary tree: as there was no damage noted to the device during the inspection prior to use, it is possible that the distal shaft was bent in the heavily calcified anatomy resulting in preventing the shaft lumens from moving freely; thus resulting in the reported activation/deployment difficulties; however this cannot be confirmed.The investigation determined a conclusive cause for the reported activation/deployment difficulties cannot be determined.During removal of the delivery system interaction with the vascular plug resulted in the reported difficult to remove.Interaction/manipulation of the compromised device resulted in the stent to heavily stretch/deform, migrate, and ultimately break.As reported, the stent migrated and became embedded in the pelvic circulation.The stent was unable to be retrieved and occluded.The reported difficulties possibly caused/contributed to the reported patient effects; however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatments appears to be related to the operational context of the procedure as balloon angioplasty was performed as treatment of the occlusion.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial report, additional information was received.It was reported the first absolute pro stent heavily stretched yet was retrieved with a retrieval catheter.The second 6.0 x 100mm absolute pro stent caught on the unspecified vascular plug, causing a complete loss of mesh structure to occur.The third absolute pro stent was deployed at the target lesion with no issues.

• 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: 18669318
• MDR Text Key: 334948858
• Report Number: 2024168-2024-01599
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072708
• 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: 04/08/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• 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: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/07/2023
• 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: 6F CROSSOVER SHEATH; ABSOLUTE PRO; UNSPECIFIED VASCULAR PLUG
• Patient Outcome(s): Required Intervention