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

Catalog Number 42045100-080

Device Problem Migration (4003)

Patient Problems Atrial Fibrillation (1729); Thrombosis (2100)

Event Date 04/04/2019

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.Exemption number (b)(4) 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 additional supera stents are being filed under separate medwatch reports.Na.

Event Description

It was reported that on (b)(6) 2019, two supera self expanding stents (6.5x150, 5.5x150mm) and a non-abbott stent were implanted in the right superficial femoral artery.On (b)(6) 2019, three supera stents (4.5x100, 5.5x150, 5.5x200mm) were implanted in the left leg from the middle third to the popliteal arteries.On (b)(6) 2019 the patient returned symptomatic and angiography confirmed thrombosis in the stents on the right side as well as the 3 other stents on the left side.There was no reported treatment for the thrombosis on the right side.One of the stents on the left side had migrated to the common femoral artery and was explanted surgically on (b)(6) 2019 during a bypass surgery.On 04/16/2019 the patient received dissection and ligation of the bypassed areas in the left lower limb.Reportedly, the patient was re-admitted on (b)(6) 2019 due to symptomatic slow atrial fibrillation.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 effect of thrombosis is listed in the supera instructions for use as a known potential patient effect associated with the use of the device.Based on the information provided, a conclusive cause for the reported stent migration and subsequent patient effects could not be determined.It may be possible that location of the stent implant in conjunction with anatomical conditions and/or repetitive movement contributed to the stent migration; however, this could not be confirmed.The surgical procedure and hospitalization are due to case circumstances as the stent was surgical ex-planted.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initially filed report, the following information was received: atherectomy was not used.A 15 mm 6fr sheath was used.For the stent that migrated, the vessel diameter was 6 mm and a smaller balloon and a 6mm balloon were used to prepare the vessel.Post procedure, the patient was ordered adiro 100mg and clopidogrel 75mg.It is unknown if the patient was compliant with the medication.The patient was admitted into emergency on (b)(6) with respiratory insufficiency.The patient died on (b)(6) due to a respiratory insufficiency.According to the physician, the supera stents are absolutely not related to the death.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: 8805481
• MDR Text Key: 151569471
• Report Number: 2024168-2019-10172
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 42045100-080
• Device Lot Number: 8052161
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SUPERA SELF EXPANDING STENT; SUPERA SELF EXPANDING STENT; SUPERA SELF EXPANDING STENT; SUPERA SELF EXPANDING STENT
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 64