MAUDE Adverse Event Report: AV-TEMECULA-CT PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1009543-12B

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problems Stroke/CVA (1770); Thrombosis (2100)

Event Date 05/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). The stent remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all relevant information. You are receiving this mdr report from abbott vascular because boston scientific corporation distributes promus as its own brand labeling of abbott vasculars drug eluting stent in the us.

Event Description

It was reported the patient had a 4. 0 x 12 mm promus stent implanted in her neck on (b)(6) 2011. After 4 years, the patient started experiencing strokes in three occasions, on (b)(6). The patient has seen her physician to see if the stent implant can be explanted and a new one implanted. Since, two major vein vessels in her head had been lost and is only working off the right blood vessel, the physician indicated there is a possibility of death if the stent is removed due to her condition and because it collapsed and full of blood clots. Additionally, she has vertigo and is going to therapy due her brain not working correctly with her left eye. No additional information was provided.

Manufacturer Narrative

(b)(4). The device was not returned for evaluation. It was reported the promus stent was implanted in the patients neck. It should be noted that the instructions for use (ifu) states: the promus everolimus eluting coronary stent system (promus stent) is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions. In this case, the violation of the ifu does not appear to have caused or contributed to the reported patient effects. The reported patient effects of cerebrovascular accident and thrombosis are listed in the promus everolimus eluting coronary stent system ifu as known patient effects of coronary stenting procedures. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. 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 the design, manufacture, or labeling of the device.

Manufacturer Narrative

(b)(4). An abbott vascular clinical specialist reviewed the reported information. The reviewer concluded the following: the carotids can sustain pressure from the outside of the next that could impact the stent structure. Also, the stents designed for coronary arteries are not designed for the type of radial resistance that a carotid artery may require. In this case, it appears the reported difficulties and subsequent patient affects are a result of the off label use of the device. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

(b)(4). The patient returned on several additional dates due to headaches, vertigo, and loss of consciousness. A diagnostic cerebral angiogram was done on (b)(6) 2016. The results showed severe restenosis causing a 99% narrowing within the stent with slow flow. The patient was recommended to discontinue coumadin, but recommended to start on plavix with her aspirin therapy. It was further reported that the stroke in (b)(6) 2016 occurred while on aspirin alone. If the patient develops recurring symptoms, balloon angioplasty was recommended. No additional information was provided. In this case, it is unknown if the patient affects are a result of the off label use of the device, therefore a conclusive cause could not be determined. The reported patient effects of cerebrovascular accident, nausea, stenosis, and thrombosis are listed in the promus everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.

Event Description

The following additional information was received: the date the promus stent was implanted is (b)(6) 2011, not (b)(6) 2011 as initially reported. Prior to procedure the patient was experiencing dizziness with extreme nausea, vertigo, diplopia. The stent was implanted in a 90% stenosis of the left vertebral artery origin. Successful procedure to restoring flow. The patient returned to the emergency room (er) on a few occasions in 2011, due to recurring dizziness, nausea, and headaches. The stent was still patent and the patient was recommended to start plavix again. The patient returned to the e. R. On (b)(6) 2016 due to headache, nausea, vomiting and abdominal pain. She was given an iv with fluids and medication and released. The patient returned on (b)(6) 2016 with a migraine, dizziness and a near syncopal experience. A brain mri showed an acute left inferior cerebral infarct, diminished flow in the intracranial left vertebral artery, and severe stenosis of the origin and proximal left vertebral artery with reconstitution of flow above this. The patient returned on (b)(6) 2016 due to vertigo, loss of consciousness, headache and a fall. The ct scan found no evidence of brain hemorrhage and no acute stroke.

• Brand Name: PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY 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: 6191287
• MDR Text Key: 62907933
• Report Number: 2024168-2016-09054
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER,HEALTH PROFESSIONAL
• Reporter Occupation: PATIENT
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/11/2017

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/20/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 10/06/2012
• Device Catalogue Number: 1009543-12B
• Device LOT Number: 0093061
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 10/01/2010
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 12/20/2016 Patient Sequence Number: 1