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

Catalog Number 42065180-120

Device Problems Stretched (1601); Difficult or Delayed Activation (2577)

Patient Problem Insufficient Information (4580)

Event Date 11/25/2021

Event Type  Injury  

Manufacturer Narrative

The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat the popliteal and superficial femoral artery that is heavily calcified and mildly tortuous.An unspecified 7.0 mm in diameter balloon was used to pre-dilate the lesion and a 6.5x180mm supera stent was advanced.During deployment of the supera it was noted the stent was being elongated (approximately 30-40mm longer than intended).Additionally, the physician tried pushing and compressing the catheter from the device to try to compress the stent it however, it was unsuccessful.The stent was deployed part in the sheath and part in the vessel.A 3 cm cut-down was performed to placed the portion of the stent in the sheath inside the artery to fully treat the artery.To close the artery wall a graft (vein dissection) was performed.Patient is noted to be stable; however, clinically significant delay was reported.The health care provider doesn't blame the device, stating he made a mistake by choosing that length.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other complaints reported from this lot.The investigation determined that the reported stent deployment difficulties and subsequent surgical intervention, delay in procedure and prolonged hospitalization were due to circumstances of the procedure.Based on the reported information, it appears that the deployment difficulty and stent elongation was due to stent size selection as it was reported that the length was too long for the treatment location.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: code 4604 was added.

• 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: 13043230
• MDR Text Key: 282551261
• Report Number: 2024168-2021-11862
• 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: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 42065180-120
• Device Lot Number: 0101361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2020
• 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: TERUMO SHEATH 6F.
• Patient Outcome(s): Disability; Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic