MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036121450
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Thrombosis (2100); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the first of 2 records.Subject device is not available.
Event or Problem Description
It was reported that during coil embolization of a ruptured distal right internal carotid artery (ica) aneurysm, during repositioning, the first subject coil and then a second coil proximal section stretched and the main coil broke.Platelet aggregation inhibitor were administered.There were attempts to retrieve the first subject coil by 2 different snare devices.Then stenting procedure by buddy wire technique was performed in the carotid bulb in order to tackle down the broken coil.The procedure was completed with complete coiling of the aneurysm.Patient clinical condition is unknown at this time.
Additional Manufacturer Narrative
Executive summary: corrected.Concomitant products grid: added.Patient code grid : corrected.Device code grid : corrected.This is the first of 3 records.
Event or Problem Description
It was reported that during coil embolization of a ruptured distal right internal carotid artery (ica) aneurysm, during repositioning, the first subject coil and then the second coil proximal section stretched and both main coils broke.There were attempts to retrieve the first coil by 2 different snare devices.A 3rd coil was placed uneventfully.Thrombus formed in the treated vessel after placement of the 3rd coil.Platelet aggregation inhibitor was administered.A stent was placed in the carotid bulb to tackle down two broken coils.Complete coiling of the aneurysm was achieved.Patient clinical condition is unknown at this time.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The complaint information stated that the coil stretched and broke during retraction and repositioning.This led to the stretched coil protruding into the parent vessel which led to thrombosis.Therefore, an assignable cause of operational context has been assigned to this investigation.Expiration date: added.Manufacturing date: added.
Event or Problem Description
It was reported that during coil embolization of a ruptured distal right internal carotid artery (ica) aneurysm, during repositioning, the first subject coil and then the second coil proximal section stretched and both main coils broke.There were attempts to retrieve the first coil by 2 different snare devices.A 3rd coil was placed uneventfully.Thrombus formed in the treated vessel after placement of the 3rd coil.Platelet aggregation inhibitor was administered.A stent was placed in the carotid bulb to tackle down two broken coils.Complete coiling of the aneurysm was achieved.Patient clinical condition is unknown at this time.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The complaint information states that the coil stretched and broke during retraction and repositioning.This led to the stretched coil protruding into the parent vessel which led to migration, unretrieved device fragments and thrombosis and subsequent patient complications.Therefore, an assignable cause of operational context has been assigned to this investigation.A medwatch report (mw 5065280) was received on 18-october-2016 regarding adverse events for the subject coils.At the time mfr report # 3008881809-2016-00260 for the 1st coil was filed with an awareness date of 18-october-2016.It was found out later by the investigation team on 11 january-2017 that mfr report # 3008881809-2016-00260 was a duplicate of mfr report # 3008881809-2016-00169.Fda has been notified in mfr report # 3008881809-2016-00260 of the duplicate issue.
Event or Problem Description
The patient presented with a ruptured large supraclinoid right internal carotid artery (ica) aneurysm with subarachnoid hemorrhage and mild hydrocephalus.During embolization of the aneurysm, the first coil (subject coil) was placed inside the aneurysm but stretched out of the aneurysm and down the vasculature and broke off the delivery wire.Following unsuccessful attempts to retrieve the coil by 2 different snare devices, stenting procedure by buddy wire technique was performed in the carotid bulb of the right ica in order to tackle down the broken coil.The same issue of stretching down the vasculature and breaking occurred with the second coil.No attempts to retrieve the second were performed.The third coil was uneventfully placed; however, after the last coil deployment thrombus formation was noted at the treated vessel.Intra-arterial integrilin was given to the patient to treat the vessel thrombosis.The procedure was completed with complete coiling of the aneurysm.The patient had long term deficit with speech, cognitive and linguistic deficits requiring 24 hour supervision for safety.It is unknown if the patient¿s condition post-procedure related to the reported devices malfunction and subsequent thrombosis or to the patient¿s presenting condition before procedure.

• Brand Name: TARGET XL 360 SOFT 14MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 5949428
• Report Number: 3008881809-2016-00169
• Device Sequence Number: 16335956
• Product Code: HCG
• UDI-Device Identifier: 04546540711540
• UDI-Public: (01)04546540711540(17)190228(10)18839198
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K123377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/03/2017

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: 02/28/2019
• Device Catalogue Number: M0036121450
• Device Lot Number: 18839198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/22/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 10/05/2016; 11/17/2016; 02/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TARGET COIL (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention