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

Catalog Number SE-05-150-120-6F

Device Problem Break (1069)

Patient Problems Neurological Deficit/Dysfunction (1982); Stenosis (2263); Claudication (2550); Diminished Pulse Pressure (2606)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

Date of event - estimate.Exemption number (b)(4).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 performed to treat an occlusion in the popliteal artery to infrapatellar segment.On (b)(6) 2019, a 5x150mm supera self-expanding stent was deployed.On (b)(6) 2019, the patient was re-hospitalized due to lameness.An angiogram was performed and restenosis was confirmed.A possible fracture to the stent was noted.A 6x150mm non-abbott balloon catheter was used to successfully treat the patient.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.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 similar incidents and/or complaints from this lot.The reported patient effects of restenosis and claudication are listed in the supera instructions for use as known potential patient effects associated with the use of the device.The investigation was unable to determine a cause for the reported stent fracture.It may be possible that the supera stent was subjected to stress/fatigue or repetitive movement due to anatomical conditions and location of the implant; however, this could not be confirmed.The additional patient effects and treatments including hospitalization are due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Code 1982 was removed.

Event Description

Additional information was received: the patient was re-hospitalized on (b)(6) 2019 due to insufficient arterial circulation in lower limb and pain in leg when walking.No additional information was provided.

• Brand Name: SUPERA PERIPHERAL STENT SYSTEM
• Type of Device: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8967348
• MDR Text Key: 156748935
• Report Number: 2024168-2019-11508
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: SE-05-150-120-6F
• Device Lot Number: 8010361
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 60