MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXSFT10 3MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DLX100306
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).The company is seeking information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.The device was discarded therefore no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l15976 number, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization, the coil of a 3mm x 6cm deltaxsft10 (dlx100306, l15976) coil delivery system came ¿back with the pusher despite a signal of detachment¿.The coil was pushed back inside the aneurysm with the pusher.There was no patient injury reported.The procedure was successfully completed.
Additional Manufacturer Narrative
(b)(4).Complaint conclusion: as reported by a healthcare professional, during an aneurysm coiling procedure, the 3mm x 6cm deltaxsft10 (dlx100306/l15976) coil came "back with the pusher despite a signal of detachment." the pusher was then used to push the coil back into the aneurysm and the procedure was completed without incident.No patient complications occurred as a result of the event and there was no surgical delay.Multiple attempts to obtain additional information were unsuccessful.The device was discarded therefore no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l15976 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿coil- protrusion into parent vessel¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Protrusion into parent vessel is a known potential complication associated with coil embolization procedures.According to the referenced literature, coil herniation into the parent artery may occasionally occur in aneurysms after coil detachment for several reasons, particularly wide-neck aneurysms.These include coil instability in the aneurysm sac, excessive embolization, microcatheter-related factors, and being pushed by subsequent coil embolization.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided; however, it is possible that clinical and procedural factors, including aneurysm/vessel characteristics, device manipulation, and device interaction, may have contributed.The file will be re-reviewed if additional information is received at a later date.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: DELTAXSFT10 3MM X 6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8871695
• Report Number: 3008114965-2019-01115
• Device Sequence Number: 311575
• Product Code: KRD
• UDI-Device Identifier: 10886704077350
• UDI-Public: 10886704077350
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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: 04/30/2022
• Device Catalogue Number: DLX100306
• Device Lot Number: L15976
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/25/2019
• 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: Required Intervention