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

Catalog Number UNK SUPERA 6F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Thrombosis (2100)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event has been estimated.Exemption number (b)(4).Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported in a vascular surgery presentation in (b)(6) titled "(b)(6)" a supera stent was implanted in the superficial femoral artery on (b)(6) 2018.Then on (b)(6) 2019, the patient was feeling symptomatic with limb ischemia and then thrombus 10mm distal and proximal to the implanted supera stent (not inside the supera) was identified.It was decided to do a laser atherectomy in the proximal and distal part to treat it.The patient had good result.However, it was noted that 10mm proximal to the supera stent there was a dissection of the artery.Another supera stent was used to treat the dissection.Per the physician, this was caused by the patients history with thrombophilia and not by the supera stent.Additionally, the physician states that the thrombus plaque noted was from not being treated in (b)(6) 2018.No additional information was provided.

Manufacturer Narrative

Date of event: estimated date of event.The udi is unknown because the part and lot numbers were not provided.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the part and lot numbers were not reported.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 case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.

• 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: 8812233
• MDR Text Key: 151745747
• Report Number: 2024168-2019-10217
• 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: 08/09/2019

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: UNK SUPERA 6F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR