MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXTRASOFT COIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLX100203
Medical Device Problem Codes	Positioning Failure (1158); Premature Activation (1484); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: krd/hcg.(b)(4).Conclusion: the deltaxsft device was not returned for analysis.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.The failure to detach the coil could not be confirmed without product return for analysis.The root cause of the failure to detach could not be determined.The coil becoming entangled with previously implanted coils resulting in coil detachment and protrusion into the parent vessel are a known procedural complication of implantation of embolic coils.The root cause of the event was most likely related to the coil becoming entangled with the previous coil and detaching when force was applied to attempt to retrieve the coil.There is no evidence to suggest that the event was related to a manufacturing issue, and procedural factors may have contributed to the event.No corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during an elective recoiling procedure of the 7 mm x 7 mm anterior communicating artery aneurysm with a 3 mm neck, a deltaxsft coil (dlx100203/ s12014) failed to detach, and during attempted retrieval, became entangled with previous coils, detached and prolapsed out of the aneurysm.The prolapsed coil was secured to the vessel wall by a stent; however, during attempt to advance the enterprise stent (enf401612/ 10621542) through a prowler select plus microcatheter (606s255x/ 17610383) friction was felt.There was no report of patient injury due to the events, and the procedure was delayed 10 minutes to implant the enterprise.There were initially two spectra coils advanced and deployed without incident (gly120510/ s11510 and dlx100254/ c41705).The third coil (complaint product) was advanced into position successfully with no resistance during advancement through the sl 10 microcatheter.During the first and only attempted detachment, the coil did not detach using the new spectra box with the orange placard (catalog/lot unk).The physician attempted to retrieve the coil; however, it became entangled with previously implanted coils and detached and prolapsed out of the aneurysm, and could not be re-advanced into the aneurysm.The event did not result in reduction of arterial blood flow.The physician attempted to place an enterprise stent into position, but reported friction in the prowler select plus.The physician removed the stent and used a second enterprise that was positioned without incident, and all subsequent coils were visualized out of the parent vessel and in the aneurysm.Neither the stent nor the microcatheter appeared damaged and a continuous flush had been maintained through the microcatheter.The same dcb and cable were used to implant subsequent coils.It was reported that a pre-deployment electrical check had been performed.A fault light had not been see during the case and upon pressing the power button, all lights illuminated as expected.The green system ready light illuminated, and during the detachment cycle, the detachment light illuminated and the audible signal beeped.All connections appeared to fit properly without application of excessive force.All coils were prepared in accordance with the ifu.It was reported that the patient was in stable condition.The devices were not available for analysis.

• Brand Name: DELTAXTRASOFT COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6356144
• Report Number: 2954740-2017-00039
• Device Sequence Number: 16404420
• Product Code: HCG
• UDI-Device Identifier: 10886704077312
• UDI-Public: (01)10886704077312(17)190831(10)S12014
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2017

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: 08/31/2019
• Device Catalogue Number: DLX100203
• Device Lot Number: S12014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 02/24/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR