MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vasoconstriction (2126)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The 5.5x120mm supera stent referenced is filed under a separate medwatch report number.

Event Description

It was reported that on (b)(6) 2016, a 5.5x120mm supera stent was implanted in the right superficial femoral artery (sfa), moderately to heavily calcified lesion without issue.Post procedure, the patient was placed on three different antiplatelet therapy medications.On (b)(6) 2016, the patient presented with ankle pain.A 5.5x150mm supera stent was implanted in the left sfa.Following, spasms were noted in the 5.5x150mm supera stent.Medication was provided and balloon angioplasty performed for the spasms.On (b)(6) 2016, the patient was hospitalized with right leg knee and shin pain.Per computerized tomography (ct) imaging, there was decreased blood flow in the right leg, containing the 5.5x120mm supera stent.On (b)(6) 2016, per right leg imaging, the brachio index was 0.2.The patient was admitted to the hospital and a catheter with fibrinolysis properties was inserted.On (b)(6) 2016, per angiography, blood clots were noted proximal to the 5.5x120mm supera stent.The catheter was removed and thrombectomy was performed.Following, 90% re-stenosis was noted in the 5.5x120mm supera stent and the stent appeared twisted.Balloon angioplasty was performed.A herculink elite was placed as treatment.Good results were noted.The patient was placed on coumadin.The event resolved without sequela.The patient was discharged from the hospital over the (b)(6).There was no additional information provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effect of vasoconstriction, as listed in the supera, instructions for use (ifu), is a known patient effect.Based on the case information and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The reported patient effect of thrombosis and restenosis, as listed in the supera, instructions for use (ifu), are known patient effects.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the previously filed medwatch report, the additional information was obtained: on (b)(6) 2016, the 4.5x80mm supera stent was implanted across the left popliteal lesion without complication and a non-abbott stent was implanted in the left superficial femoral artery (sfa).The procedure was performed with no complications and successful stenting.On (b)(6) 2016, per imaging, the left popliteal 4.5x80mm (not 5.5x150) supera stent placed on (b)(6) 2016, had totally occluded.Additional heparin was provided and balloon angioplasty was performed.A small amount of thrombus was observed and the lesion had become spasmodic.Mild plaque was noted between the (b)(6) 2016 left popliteal and left sfa stents.Nitroglycerine was provided and additional balloon angioplasty was performed.A 5.5x120mm supera stent was implanted across the left popliteal lesion without difficulty.Post dilatation was performed.A small amount of residual thrombus, distal to the stent was noted.The procedure was tolerated well.

• Brand Name: SUPERA SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5821198
• MDR Text Key: 50390330
• Report Number: 2024168-2016-04931
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 53