MAUDE Adverse Event Report: COVIDIEN (IRVINE) SOLITAIRE FR3; CATHETER, THROMBUS RETRIEVER

Model Number	SFR3-6-20-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned as it was discarded by the customer.The cause of the vasospasm cannot be reliably determined; however, based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during mechanical thrombectomy procedure with the solitaire device, patient experience vasospasm and ¿intraarterial nimodipine 2 mg.(vasospasm)¿ was performed.It was reported that the patient was admitted to the treating hospital for an acute ischemic stroke with a pre-procedure nihss of 18.The subject had a pre-procedural mtici score of 0 and underwent mechanical thrombectomy procedure with the solitaire stent.It was reported that after final pass with the solitaire device, we found that the left insular branch of mca was still occluded with suspected vasospasm.The tici 2b was observed.Then, infused intra-arterial nimodipine, after that the insular branch was complete recanalized.Tici 3 was observed.The vasospasm maybe occurred after retrieved the stent or anytime during thrombectomy.The subject had a 24-hour post procedure nihss of 15.The patient has atrial fibrillation (af), ht.After thrombectomy, patient, she has improved power motor with mild aphasia with ct showed hemorrhagic transformation at left basal ganglia.After 2 weeks from thrombectomy, the warfarin was prescribed.The discharge mrs score was updated to 4.The discharge nihss score was changed to 5.

• Brand Name: SOLITAIRE FR3
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8142737
• Report Number: 2029214-2018-01034
• Device Sequence Number: 1910176
• Product Code: NRY
• UDI-Device Identifier: 00847536020542
• UDI-Public: 00847536020542
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K153071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/18/2020
• Device Model Number: SFR3-6-20-10
• Device Lot Number: A636289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/07/2018
• 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
• Patient Age: 70 YR
• Patient Weight: 54