MAUDE Adverse Event Report: COOK INC TORNADO PLATINUM EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/06/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6fr pigtail catheter, judkins catheter (cordis).Pma/510(k) #: preamendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.[(b)(4)].
Event or Problem Description
The below description of a tornado platinum embolization coil migration was taken from the following literature article: tri-linh christian lu, salah dine qanadli."percutaneous retrieval of a migrated coil in the left atrium." radiology case reports (2010); 5.4: 335.The following was stated in the article: "a (b)(6)-year-old woman with hereditary telangiectasia underwent a helical ct scan to assess the presence of a pavm that was first visualized on a standard chest x-ray.The malformation was located in the anterior basal segment of the right lower lobe.The aneurysmal sac was 30 × 25 mm.The feeding artery was unique and was 9 mm wide.The venous drainage consisted of one simple vein (fig.1).These findings correspond to a simple type pavm (6), as opposed to a complex type with multiple feeding arteries and draining veins." "after obtaining informed consent, we performed an embolization procedure under local anesthesia via a right transfemoral venous approach.A 6-french pigtail catheter was inserted into the right pulmonary artery, and angiography was performed (fig.2a).In order to exclude the pavm, a right coronary [other manufacturer catheter] was advanced to the distal part of the feeding vessel, and a short tornado coil mwce-35 5/10 mm [cook medical] was deployed with the small end first.Immediately after the insertion of the coil, it migrated into the aneurysmal sac.A rapid occlusion of the afferent artery was intended to reduce the inflow pressure.The coil, however, moved distally a few seconds later and ended up lodged in the left atrium.The patient remained asymptomatic, and no abnormalities were observed on the electrocardiogram (ecg).The coil seemed unstable on fluoroscopy, with a high mobility for several seconds, and then stabilized by adhering to the leaflets of the mitral valve (fig.2b)." "after an intravenous injection of 5000 ui of heparin, the decision was taken to try a transvalvular approach through a right arterial femoral access.In order to preserve the mitral apparatus, it was decided not to use a snare directly.The left atrium was catheterized in a retrograde fashion through the aortic valve and then through the mitral valve.A 6f internal mammary guiding catheter [other manufacturer] was then used to dislodge the coil under fluoroscopic guidance and continuous ecg monitoring.With gentle taps on the proximal end of the coil, the distal end moved up to the aortic valve, where it was suitable for a safe removal with a 25-mm amplatz goose neck snare [other manufacturer], using the same guiding catheter (fig.3)." "because of the length of the intervention, it was decided to postpone the embolotherapy of the pavm for another session.A cardiac mri performed after the intracardiac procedure showed no lesions or dysfunction of the mitral apparatus.Two weeks later, the procedure was successfully achieved with the insertion of three coils of 0.018-inch mwce tornado 10/5 mm and three coils of 0.018-inch mwce 8/5 mm (cook medical).One month after the embolotherapy, computed tomography confirmed occlusion of the pavm." per the article, no other adverse effects were reported for these incidences.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: b3 ¿ date of event: the date previously reported was the date of online publication, original publish date was sometime in 2010 d4- product lot number: unknown h6 ¿ additional method code: device not returned (4114) investigation ¿ evaluation a literature article, ¿percutaneous retrieval of a migrated coil in the left atrium¿ volume 5, issue 4, 2010 was discovered by a cook employee.The authors for the article are tri-linh christian lu md and salah dine qanadli md, phd.According to the article, during an embolization procedure, a cook tornado coil was deployed and immediately migrated into aneurysmal sac.Shortly thereafter, it migrated to the left atrium where it was described as ¿unstable¿ but eventually it stabilized on leaflets of the mitral valve.The coil was removed, and cardiac mri done after this procedure did not show mitral apparatus dysfunction.No other adverse effects were reported.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.The literature article included an image of the failure in figure 2 b with the description ¿distal migration of the coil into the left cardiac chambers (black asterisk).¿ there is also an image in figure 3 of using a snare loop device to remove the migrated coil after dislodging in from the mitral apparatus.These images confirm the migration of the coil within the patient.Additionally, a document-based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits and all tested devices met the acceptance criterion for radial force and fiber security testing of tornado platinum embolization coils.The instructions for use (ifu) and product labeling were reviewed.Relevant information for the failure mode includes: warnings: "positioning of embolization coils should be done with particular care.Coils should not be left too close to the inlets of arteries and should be intermeshed with previously placed coils if possible.A minimal but sufficient arterial blood flow should remain to hold the coils against the previously placed coils until a solid clot ensures permanent fixation.¿ precautions: "perform an angiogram prior to embolization to determine correct catheter position.¿ instructions for use: for 0.035 and 0.038 inch coils: ¿1.Perform an angiogram prior to embolization to determine optimal catheter position.4.With the flexible tip of the wire guide, advance the embolization coil to the tip of the catheter.Verify position of the angiographic catheter prior to deployment.5.Deploy the coil by advancing the wire guide past the tip of the catheter.6.Perform final angiogram to confirm coil position within target vessel.¿ the article stated the coil was a "tornado coil mwce-35 5/10 mm" but a lot number and rpn was not provided.Based on the description, it was determined the coil was either a mwce-35-10/5-tornado-01 or mwce-35-10/5-tornado device.A global sales shipment report was conducted from 01jan2005 through 31dec2010 for rpn: mwce-35-10/5-tornado-01 and mwce-35-10/5-tornado.The customer only purchased rpn: mwce-35-10/5-tornado from 6 lots over this time period.The device history record (dhr) was reviewed for the six potential lots.A complaints database search was completed on these six lots and no complaints were found.A non-conformance search was completed on these six lots and no non-conformances related to the failure mode were found.As there are adequate inspection activities established, objective evidence that the dhr was fully executed, no related non-conformances and no complaints from the lots, it was concluded that there is no evidence that nonconforming product exists in house or in field.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specification.Migration is possible if the coil is not properly sized to the targeted vessel location.The article states ¿the small end of the coil (5mm) was undersized compared to the vessel.With the small end introduced first, there was no possibility to firmly anchor the coil, which was doomed to unwind and to migrate distally." this likely contributed to the migration into the left atrium of the patient because the 5 mm end of the coil was undersized compared to the target vessel.Based on the information provided, no returned product, and results of the investigation, it was concluded that the cause of the event was an unintended user error.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: TORNADO PLATINUM EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10006221
• Report Number: 1820334-2020-00879
• Device Sequence Number: 17006380
• Product Code: KRD
• UDI-Device Identifier: 00827002104136
• UDI-Public: (01)00827002104136(17)180501(10)4281875
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2018
• Device Model Number: N/A
• Device Catalogue Number: MWCE-35-10/5-TORNADO
• Device Lot Number: 4281875
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 34 YR