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

Catalog Number 42045150-120

Device Problems Material Separation (1562); Stretched (1601); Activation Failure (3270)

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

Event Date 11/10/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the heavily calcified superficial femoral artery (sfa).The vessel diameters were 5 mm, 4.2-4.5 mm, atherectomy was not used and the lesion was pre-dilated for 30 seconds with a 5x150 mm balloon at 16 atmospheres, the 4.5x150 mm supera self expanding stent (ses) had been implanted in the sfa and popliteal arteries when it was noted that the tip of the delivery system had separated and was located inside the sheath.A portion of the stent was deployed in the sheath.The sheath was removed with the tip inside and it was noted that the stent had also been removed and was located in the sheath and was elongated.When the sheath was completely removed, the stent was outside of the artery.Therefore, the stent was completely and safely pulled out from the anatomy under fluoroscopy.It was confirmed there was no issue with the artery and the lesion was then treated with a drug coated balloon.There were no adverse patient effects and there was a delay in the procedure; however, no harm to the patient was reported.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.

Manufacturer Narrative

The device was not returned for analysis.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 stent deployment the sheath was too close to the proximal end of the stent resulting in the stent inadvertently partially deploying into the sheath and/or during device removal the tip of the device inadvertently got caught on the deployed stent; thus as the compromised device and stent were withdrawn into the sheath it resulted in the reported stretched stent, the reported tip material separation and thus resulted in the reported activation/deployment failure.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3 - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.

• 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: 18240704
• MDR Text Key: 329552210
• Report Number: 2024168-2023-13255
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: DR
• 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: 02/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42045150-120
• Device Lot Number: 2083161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 02/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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: 6FR 45 CM SHEATH; COMMAND GUIDE WIRE
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic
• Patient Race: Black Or African American