MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

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

Patient Problems Intimal Dissection (1333); Angina (1710); Embolism (1829); Ischemia (1942); Myocardial Infarction (1969); Renal Failure (2041); Thrombosis (2100)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event, implant date - estimated dates.The stents remain in the patients.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The device issue reported in the article is filed under a separate mfr report #.Article titled: "femoropopliteal artery stent thrombosis: report from the excellence in peripheral artery disease (xlpad) registry.".

Event Description

It was reported through a research article of 604 patients between may 2005 to january 2015 identifying supera self-expanding stent system (sess) that was related to major adverse peripheral events of stent thrombosis [sub-acute, late], and may be related to dissection, angina, embolism, ischemia, myocardial infarction, renal failure, revascularization, surgical intervention, and hospitalization.Details are listed in the article titled "femoropopliteal artery stent thrombosis: report from the excellence in peripheral artery disease (xlpad) registry.".

Manufacturer Narrative

Internal file number - (b)(4).The unique device identifier (udi) is unknown because the part and lot numbers were not provided.The device was not returned for evaluation.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 effects of dissection, angina, pulmonary embolism, ischemia, myocardial infarction, renal failure and surgery are known potential patient effects as listed in the supera instructions for use.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.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8363785
• MDR Text Key: 136928780
• Report Number: 2024168-2019-01369
• 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: literature
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 02/26/2019
• Supplement Dates FDA Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 64 YR