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

Catalog Number	DLF180835
Medical Device Problem Code	Difficult To Position (1467)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The deltafill will not be returned, therefore the root cause of the positioning difficulty cannot be determined.Dhr: 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.Common device name: procode: krd/hcg.
Event or Problem Description
The contact at the hospital reported that the deltaxsft coil (dlx100206/c41704) could not advance through the microcatheter and the deltafill coil (dlf180835/s11465) did not optimally conform to the aneurysm.The first aneurysm was a right posterior communicating artery (pcom) measuring 4mm.A stryker sl-10 microcatheter was inserted and the deltaxsft coil (dlx100206/c41704) was attempted to be inserted after framing with two stryker target coils at the pcom.Prep of the deltaxsft began with inserting the green introducer sheath into a bowl of normal saline and pushing the coil out into the saline to hydrate the coil then withdrawing the coil back into the sheath.The introducer of the deltaxsft 2x6 was inserted into the touhey rhv and hubbed into the sl-10 microcatheter.Upon unlocking the pusher wire and transferring the coil into the sl-10 the pusher wire hub-connector was roughly 6 inches from meeting the resheathing tool before the doctor could no longer advance the pusher wire.The doctor then held the translucent sheath and pusher wire and advanced the re-sheathing tool down to the green introducer then pulled both the green introducer and re-sheathing tool back toward the hub-connector.The doctor then loosened the touhey to advance the pusher wire/coil further into the sl-10 microcatheter.The deltaxsft 10 2x6 coil would not advance further into the microcatheter and was removed without patient incident or harm, coil was discarded.The second aneurysm was a right internal carotid artery (ica) aneurysm measuring around 10 mm in diameter (complex shape.) the aneurysm was successfully framed with a deltafill 18 10x40 a deltafill 18 8x35 coil (both details unknown) without issue.The coils were prepped in the same manner as the deltaxsft coil by inserting the coil into a bowl of saline to hydrate the coil before inserting into the stryker sl-10 microcatheter.Then a deltafill coil (dlf180835/s11465) was inserted into the right ica aneurysm without incident or patient harm, but the doctor commented that the deltafill 18 8x35 did compartmentalize in the aneurysm (not an optimal fill) but the coil detached on first fire.The doctor then finished the coiling procedure with three additional stryker target coils.Post procedure the patient awoke alert and oriented.

• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6132366
• Report Number: 2954740-2016-00285
• Device Sequence Number: 19144597
• Product Code: KRD
• UDI-Device Identifier: 10886704077220
• UDI-Public: (01)10886704077220(17)190630(10)S11465
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: DLF180835
• Device Lot Number: S11465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2016
• Initial Report FDA Received Date: 11/29/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STRYKER SL-10 150MM
• Patient Age: 68 YR