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

Catalog Number SE-06-100-120-6F

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

Patient Problems Pain (1994); Thrombosis (2100); Numbness (2415)

Event Date 08/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: stent: rx xience prime 3.0 x 38mm, rx xience prime 3.0 x 33 mm.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.The reported patient effects of pain and thrombosis are listed in the supera instructions for use as known patient effects associated with the use of the device.Based on the case information and related record review, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue.The xience prime 3.0x38 and 3.0x33 devices, referenced, are filed under separate medwatch manufacturer report reference numbers.

Event Description

It was reported that the patient underwent a procedure, with implantation of one supera self-expanding stent and two xience prime below the knee (btk) stents.The supera was implanted in the popliteal artery, with the xience prime btk stents implanted in a kissing fashion in the tibioperoneal trunk and the anterior tibial artery all on (b)(6) 2017.That evening, the patient complained of numbness and pain in his foot.Computed tomography angiography (cta) showed complete thrombosis from the distal superficial femoral artery down to the xience prime (3.0 x 38 mm and 3.0 x 33 mm) stents.The supera had thrombosed mid-stent causing both xience prime stents to block as well.Aspiration thrombectomy with short thrombolysis was performed on (b)(6) 2017.The patient had prolonged hospitalization and was treated with overnight lysis.Patient was discharged on (b)(6) 2017.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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6828730
• MDR Text Key: 83936863
• Report Number: 2024168-2017-07062
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: SE-06-100-120-6F
• Device Lot Number: 6100561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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: 66 YR