MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number NOT REPORTED

Device Problems Positioning Failure (1158); Migration (4003)

Patient Problems Aneurysm (1708); Death (1802); Pulmonary Emphysema (1832)

Event Date 06/15/2019

Event Type  Death  

Manufacturer Narrative

Balt usa's reference number: (b)(4).To whom it may concern: on (b)(6) 2020, balt usa has been notified of an event regarding the use of a single optima coil.Details reported as follows: "after framing with the 2.5x2.5 optimax the physician detached the coil and opened a 1.5x2 optimax but felt like the first coil was moving the second he then switched to a 1.5x2 css optima and it still moved the frame.He lost catheter positioning and went to re-access the aneurysm when he placed the synchro back in the aneurysm the coil was dislodged, and he had to retrieve it with a stent retriever.The coil came out and he went back in with a comaneci and framed with a 2.5x5 optimax which set up well.He finished with 5 css optima coils.Two things were noted by the physician.First the 2.5cm length did not allow the coil to create a complete frame in all directions which may have allowed the coil to move when the wire hit it.Second, compared to the target xl soft the optimax super soft may not have the same body and structure.He suggested that it is too early to know for sure, but we may want to consider creating a 2,2.5,3, and 3.5mm soft optimax." an evaluation of the actual complaint sample could not be performed as the device was unavailable for return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.Review of the lot history record did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f200500099 has been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.

Event Description

It was reported through an automated reporting system from active clinical study: "after framing with the 2.5x2.5 optimax the physician detached the coil and opened a 1.5x2 optimax but felt like the first coil was moving the second he then switched to a 1.5x2 css optima and it still moved the frame.He lost catheter positioning and went to re-access the aneurysm when he placed the synchro back in the aneurysm the coil was dislodged, and he had to retrieve it with a stent retriever.The coil came out and he went back in with a comaneci and framed with a 2.5x5 optimax which set up well.He finished with 5 css optima coils.Two things were noted by the physician.First the 2.5cm length did not allow the coil to create a complete frame in all directions which may have allowed the coil to move when the wire hit it.Second, compared to the target xl soft the optimax super soft may not have the same body and structure.He suggested that it is too early to know for sure, but we may want to consider creating a 2,2.5,3, and 3.5mm soft optimax.".

Manufacturer Narrative

Balt usa's reference number: (b)(4).To whom it may concern: on july 6, 2020, balt usa has been notified of an event regarding the use of a single optima coil.Details reported as follows: it was reported through an automated reporting system from active clinical study: "a serious adverse event was added: site id: #105.Patient id: (b)(6).Year of birth: 1954.Adverse event form number: #3.Event description: patient deceased.Date of event onset: (b)(6) 2020.Seriousness: led to a death.Relationship to optima coils system: event status: death.Date of event resolution or death: (b)(6) 2020.Created by: (b)(6).Date of creation: 7/3/20 1:23 pm.Follow up provided (07/17/2020): 'the death occurred several months after the procedure with optima coils in another hospital not involved in the instant study that is why we have difficulties to collect the relationship to the study device.The hospital where the death occurred inform us that the report will be available after 10th of august ( due to holidays )and not before.The instant study site staff where the patient was enrolled ( french site in bordeaux) doesn't think that the event is linked to the optima but to be sure we need to wait for the death report (from the other hospital) sorry for that but we cannot do anything more for the moment.' a serious adverse event was updated: site id: #105.Patient id: (b)(6).Year of birth: 1954.Adverse event form number: #3.Event description: pulmonary disease.Date of event onset: (b)(6) 2020.Seriousness: led to a death.Relationship to optima coils system: not related.Relationship to procedure: not related.Relationship to a balt device: no.Action: medication.Event status: death.Date of event resolution or death: (b)(6) 2020 updated by: (b)(6)." an evaluation of the actual complaint sample could not be performed as the device was unavailable for return.Based on the provided information, root cause could not be definitively determined.Upon follow up with clinical site, it has been determined that the disease progression is not related to the optima coil system nor coiling procedure.The lot number was not provided therefore; a review of the lot history records could not be performed.The submission of this report or related information to the fda, and its release by fda, does not reflect a conclusion by the party submitting this report of the fda that the report or related information is an admission that the manufacturer, their employees, or the device caused or contributed to the reportable event.

Event Description

It was reported through an automated reporting system from active clinical study: "a serious adverse event was added: site id: #105.Patient id: (b)(6).Year of birth: 1954.Adverse event form number: #3.Event description: patient deceased.Date of event onset: (b)(6) 2020.Seriousness: led to a death.Relationship to optima coils system: relationship to procedure: relationship to a balt device: if yes, specify device: if yes, specify relationship: other relationship: if yes, specify: action: event status: death.Date of event resolution or death: (b)(6) 2020.Created by: (b)(6).Date of creation: 7/3/20 1:23 pm.Follow up provided (07/17/2020): 'the death occurred several months after the procedure with optima coils in another hospital not involved in the instant study that is why we have difficulties to collect the relationship to the study device.The hospital where the death occurred inform us that the report will be available after 10th of august ( due to holidays )and not before.The instant study site staff where the patient was enrolled ( french site in bordeaux) doesn't think that the event is linked to the optima but to be sure we need to wait for the death report (from the other hospital) sorry for that but we cannot do anything more for the moment.' a serious adverse event was updated: site id: #105.Patient id:(b)(6).Year of birth: 1954.Adverse event form number: #3.Event description: pulmonary disease.Date of event onset: (b)(6) 2020.Seriousness: led to a death.Relationship to optima coils system: not related.Relationship to procedure: not related.Relationship to a balt device: no.If yes, specify device: if yes, specify relationship: other relationship: if yes, specify: action: medication.Event status: death.Date of event resolution or death: (b)(6) 2020.Updated by: (b)(6).".

• Brand Name: OPTIMA COIL SYSTEM
• Type of Device: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine, ca
• MDR Report Key: 10431348
• MDR Text Key: 203690799
• Report Number: 3014162263-2020-00016
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053025013
• UDI-Public: 00818053025013
• Combination Product (y/n): N
• PMA/PMN Number: K200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT REPORTED
• Device Catalogue Number: N/A
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention