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

Catalog Number S-45-120-120-P6

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

Patient Problem Occlusion (1984)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).There was no reported device malfunction, and the product was not returned.The reported patient effect of occlusion is listed in the supera instructions for use.Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication the reported patient effects were caused by, or related to the design, manufacture or labeling of the device.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.The 5.5x100mm supera referenced is being filed under a separate medwatch mfr number.

Event Description

It was reported that two supera stents (4.5 x 120 mm, 5.5 x 100 mm) were implanted on (b)(6) 2015.On an un-specified date, it was found that the stents were occluded; therefore, an additional procedure was performed on (b)(6) 2015 for treatment.Balloon angioplasty was performed and the patient had a good outcome.No additional information was provided.

• 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
• Manufacturer (Section G): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5212363
• MDR Text Key: 30832170
• Report Number: 2024168-2015-06671
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/09/2015

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
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: S-45-120-120-P6
• Device Lot Number: 02250056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 79