MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAMAXX - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDX18062530
Medical Device Problem Codes	Stretched (1601); Device Operates Differently Than Expected (2913); Difficult to Advance (2920)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This initial mdr will be the only report submitted for mfr report #2954740-2017-00198.This initial mdr is the only report being submitted for mfr report #2954740-2017-00198.(b)(4).Concomitant medical products: sheath introducer (6fr jsheath), guide wire (naveed 4, terumo), guiding catheter (5fr small cobra), microcatheter (progreat lambda, terumo).(b)(4).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that two deltamaxx coils (cdx181040-30/s10881 & cdx180625-30/s12652) were used during a coil embolization procedure of an aneurysm for a type ii endoleak at the lumbar iia where resistance was experienced between both deltamaxx coils and the microcatheter; however, the first deltamaxx coil (cdx181040-30/s10881) could not be delivered at all and the second deltamaxx coil (cdx180625-30/s12652) got stuck and became unraveled.An ipsilateral approach was made from the iia and a guiding catheter was advanced to the ileostomy artery.The ileocolic artery was connected to the abdominal aortic aneurysm and the decision was made to return from the tip.Coil embolization was conducted with galaxy, axurcx, terumo clinical supply, and deltamaxx.Deltamaxx complaint coil 1 (cdx181040-30/s10881) was used in the middle of the procedure, but strong resistance was felt from the tip of the catheter to the middle.The coil could not be delivered at all.Deltamaxx complaint coil 2 (cdx180625-30/s12652) was used at the end of the procedure and resistance was felt.The coil was in and out, repeatedly, and an attempt was made to re-sheath the coil.The coil got stuck somewhere and became unraveled; however, the physician did not notice that the coil had unraveled so it was extended to the vicinity of the external iliac artery.It became difficult to retrieve the coil, so a smart control stent (10mm x 40mm) was deployed and the coil was put on the vessel wall.The procedure was completed, but due to the event, it was delayed for 30 minutes.The patient was a male, age unknown.The patient's vessel was moderately tortuous and calcification was unknown.A sheath introducer (6fr jsheath), a guide wire (naveed 4, terumo), a guiding catheter (5fr small cobra), a microcatheter (progreat lambda, terumo) were also used for this procedure.There was no patient injury/complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.Deltamaxx complaint coil 1 (cdx181040-30/s10881) is available for investigation.No further information is available.
Additional Manufacturer Narrative
The deltamaxx was not returned for investigation.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.There is no current safety signal identified related to the reported event based on review of complaint history for the device.

• Brand Name: DELTAMAXX - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6703574
• Report Number: 2954740-2017-00198
• Device Sequence Number: 16516874
• Product Code: KRD
• UDI-Device Identifier: 10878528008573
• UDI-Public: (01)10878528008573(17)211031(10)S12652
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2017

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: 10/31/2021
• Device Catalogue Number: CDX18062530
• Device Lot Number: S12652
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 09/11/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention