MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO .035 SELF EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Catalog Number 1011916-100

Device Problems Difficult to Remove (1528); Stretched (1601); Activation Failure (3270)

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

Event Date 10/25/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat the heavily calcified, moderately tortuous, 90% stenosed external iliac artery.The patient was going to have a right common femoral endarterectomy as well and this was performed first without issue.Then a 6fr sheath was placed through the patch on the ipsilateral side and an.035 supra core guide wire was used.No pre-dilatation was performed and the 7x100 mm absolute pro self expanding stent system (sess) was advanced to the lesion.Deployment was attempted and the thumbwheel was rolled completely until it stopped; however, the stent only deployed 1 cm.The delivery system and stent were then pulled down to the site of the endarterectomy, and resistance was noted with the vessel.The device was attempted to be removed but the stent elongated significantly across the target lesion.The elongated stent was cut and part was left in situ.Next, a 7x59 mm omnilink elite stent delivery system was advanced to the lesion and significant resistance was felt so it was decided to remove the device.The omnilink elite sds only partially reached the lesion due to resistance with the anatomy.In removing the device, the stent came completely off of the balloon and was retrieved through the endarterectomy site with a pair of long angled forceps.The groin was then closed and no further stenting was attempted.There were no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional omnilink elite device referenced in b5 is captured under a separate medwatch number.

Manufacturer Narrative

The device was returned for analysis.The reported activation failure was unable to be replicated in a testing environment due to the condition of the returned device.The reported difficult to remove and the reported stretched - stent were unable to be replicated in a testing environment as they were based on operational circumstances.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, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with the very heavily calcified anatomy resulted in preventing the shaft lumens from moving freely resulting in the reported difficulty deploying the stent.Manipulation of the device resulted in the noted wrinkled sheath likely contributing to the reported difficulty deploying the stent.As the delivery system and stent were then pulled down to the site of the endarterectomy resistance was noted with the heavily calcified vessel resulting in the reported difficult to remove and the reported stretched- stent.Reportedly, the portion of the absolute pro stent which remained in the anatomy covered the target lesion and the stent was cut with heavy duty surgical scissors.The noted handle gap and sheath separation likely occurred during packing for return analysis as the account confirmed they were not aware of the separation.The treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat the heavily calcified, moderately tortuous, 90% stenosed external iliac artery.The patient was going to have a right common femoral endarterectomy as well and this was performed first without issue.Then a 6fr sheath was placed through the patch on the ipsilateral side and an.035 supra core guide wire was used.No pre-dilatation was performed and the 7x100 mm absolute pro self expanding stent system (sess) was advanced to the lesion.Deployment was attempted and the thumbwheel was rolled completely until it stopped; however, the stent only deployed 1 cm.The delivery system and stent were then pulled down to the site of the endarterectomy, and resistance was noted with the vessel.The device was attempted to be removed but the stent elongated significantly across the target lesion.The elongated stent was cut and part was left in situ.Next, a 7x59 mm omnilink elite stent delivery system was advanced to the lesion and significant resistance was felt so it was decided to remove the device.The omnilink elite sds only partially reached the lesion due to resistance with the anatomy.In removing the device, the stent came completely off of the balloon and was retrieved through the endarterectomy site with a pair of long angled forceps.The groin was then closed and no further stenting was attempted.There were no adverse patient sequela.Subsequent to the initially filed mdr report it was reported that the portion of the absolute pro stent which remained in the anatomy covered the target lesion and the stent was cut with heavy duty surgical scissors.The sheath of the device was separated; however, the account was not aware of the separation.No additional information was provided.

• Brand Name: ABSOLUTE PRO .035 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: 18132329
• MDR Text Key: 328064275
• Report Number: 2024168-2023-12618
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1011916-100
• Device Lot Number: 3072161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2023
• 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: 6FR SHEATH.; SUPRA CORE GUIDE WIRE.
• Patient Outcome(s): Required Intervention