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

Catalog Number 42050120-120

Device Problems Material Separation (1562); Difficult to Advance (2920); Mechanical Jam (2983); Activation Failure (3270)

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

Event Date 05/12/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a moderately calcified, moderately tortuous right distal superior femoral artery (sfa).The patient was treated crossover, puncturing the left common femoral artery and the bifurcation was noted to be stiff.The lesion was prepped with an unspecified 6mm balloon for five minutes at rate burst pressure.The 5.0x120mm supera self-expanding stent system (sess) was advanced to lesion with some resistance felt with anatomy; however, during deployment the stent partially deployed.It was not possible to open the second red lock to release the last proximal section of the stent.It was attempted to retrieve the supera back into the sheath, but the delivery system separated at the distal shaft.Fortunately, the olive got stuck in the stent.The delivery system was removed under fluoroscopy.The 6f sheath was replaced with an 11f and was able to snare the separated portion and remove from the anatomy.To end the procedure the lesion was treated with a new 5.0x100mm supera.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported material separation was able to be confirmed.The reported mechanical jam was unable to be confirmed.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 advance was unable to be replicated in a testing environment as it was 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 resistance was met with the moderately calcified, moderately tortuous anatomy resulting in the reported difficult to advance.During stent deployment it is likely that the distal sheath of the delivery system was entrapped or bent in the moderately calcified, moderately tortuous anatomy and the noted stiff bifurcation resulting in the noted device damages (entire length of the sheath bent sporadically, chatter marks/bends sporadically on the entire length of catheter shaft) such that the ratchet was unable to properly/fully deploy the stent resulting in the reported activation/deployment failure and the reported mechanical jam.Interaction/manipulation of the device in an attempt to retrieve the supera back into the sheath ultimately resulted in the reported material separation/noted tip jacket and inner member separations.The treatment(s) appears to be related to the operational context of the procedure as reportedly the 6f sheath was replaced with an 11f and was able to snare the separated portion and remove from the anatomy.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: SUPERA 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: 17074052
• MDR Text Key: 316661001
• Report Number: 2024168-2023-05959
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P120020
• 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: 07/28/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 42050120-120
• Device Lot Number: 2102761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• 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: TERUMO DESTINATION 6F CROSSOVER SHEATH
• Patient Outcome(s): Required Intervention