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Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Muscle Weakness (1967); Transient Ischemic Attack (2109); Pseudoaneurysm (2605); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2020
Event Type  Injury  
Manufacturer Narrative
Patient reported age (57 years) is representative of the mean age for all patients included in the study. Patient reported sex (female) is representative of the majority of patients in the study. If information is provided in the future, a supplemental report will be issued.
Event Description
Linfante, i. , andreone, v. , ravelo, n. , starosciak, a. K. , arif, b. , shallwani, h. , tze man kan, p. , mcdermott, m. W. , dabus, g. (2020). Endovascular treatment of giant intracranial aneurysms. Cureus, 12(5), e8290. Https://doi. Org/10. 7759/cureus. 8290 abstract objective: giant intracranial aneurysms (gias) are associated with a high risk of rupture and have a high mortality rate when they rupture (65-100%). The traditional microsurgical approach to secure these lesions is challenging, and as such endovascular embolization has been increasingly selected as a treatment option. Methods: we performed a retrospective analysis of consecutive patients with ruptured and unruptured gias at three medical centers from october 2008 to april 2016. Clinical follow-up and digital subtraction angiography were conducted at six months post-treatment. Chi-square analysis was used to determine differences in outcomes between anterior and posterior circulation aneurysms and if a pipeline embolization device (ped) provided favorable outcomes in unruptured gias. Results: a total of 45 consecutive patients (mean/median age
57/59; range: 16-82 years) were included. The mean/median aneurysm size was 29. 9/28. 3 mm (range: 25-50 mm). Eight (18%) patients presented with aneurysmal subarachnoid hemorrhage and 37 (82%) with unruptured gias. Twenty-eight (62%) were treated with a ped: 11 (24. 4%) with one ped, 1 (2. 2%) with ped + coils, 11 (24. 4%) with more than one ped, and 5 (13. 5%) with multiple ped + coils. The overall mortality rate was 3/45 (6. 7%). No deaths were procedure-related. Five (11. 1%) patients experienced ischemic stroke but only 2 had a 90-day modified rankin scale (mrs) score of
3. Of 33 patients available for six-month angiography, raymond scale (rs) scores were 1, 2, and 3 for 23/45 (70%), 7/45 (20. 9%), and 3/45 (9. 1%), respectively. Chi-square test demonstrated that overall, anterior circulation gias had better clinical (mrs score) and radiographic (rs score) outcomes than posterior gias. Ped alone provided similar clinical mrs outcomes but had a higher rate of complete occlusion at six months compared with ped + coils and coils alone in unruptured gias (p <(><<)> 0. 05). Conclusions: endovascular embolization using ped or ped + coils appears to be a moderately safe and effective treatment option for patients with gias. 3 patients included in the study and all of whom were treated with implantation of multiple ped's experienced stroke which resulted in symptoms and/or increased mrs. The first patient was treated for an unruptured 25. 3mm aneurysm of the right middle cerebral artery and had two ped's implanted and coiling. This patient developed completed ped occlusion and right lentiform and caudate nucleus infarct with clinical worsening demonstrated by report of pre-procedure mrs score of 2 and 90-day mrs score of 4, but 6 month mrs score was 1. The patient was treated with mechanical thrombectomy of the embolism and medication; treatment was successful. The second patient was treated with three implanted ped's and coiling to treat an unruptured 30mm basilar and left ventricular artery. The pre-procedure mrs score was 3, which worsened to 4 at 90 days. The third patient was treated for an unruptured 30mm aneurysm of the left ventricular artery with 9 ped's implanted. This patient experienced a left thalamic stroke which caused right hand weakness, but the mrs score at 90 days was 3, which was the same as pre-procedure. Another patient, treated for an unruptured 50mm aneurysm of the right internal carotid artery (r-ica) with 2 ped's and coiling, developed a pseudoaneurysm of the femoral artery. Additional treatment was provided to evacuate the hematoma from the femoral artery pseudoaneurysm with a drain. Two patients had an intraoperative transient ischemic attack (tia) which was treated with integrillin. One of these patients also developed post-operative subarachnoid and intraparenchymal hemorrhage which were treated with craniectomy and clot evacuation; 2 additional ped's were also implanted for residual aneurysm. This patient presented with a mrs score of 2; at 90 days, the mrs score was 4 and at 6 months the patient was recovered with an mrs score of 1. Another patient treated for an unruptured 27mm aneurysm of the r-ica with implantation of a ped had residual aneurysm; 2 additional ped's were implanted. There was also a patient treated for an unruptured 27. 9mm aneurysm of the l-ica which had incomplete coverage of the aneurysm. A follow-up procedure was planned for implantation of multiple additional ped's.
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Manufacturer (Section D)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
MDR Report Key11018920
MDR Text Key222070814
Report Number2029214-2020-01317
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberNOT-RPT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/16/2020 Patient Sequence Number: 1