MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Lot Number 4040241

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

Patient Problems Myocardial Infarction (1969); Pain (1994); Stenosis (2263)

Event Date 02/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The asahi, two 2.25x28mm xience alpine, and two unk xience v devices referenced are being filed under a separate medwatch mfr number.There was no reported device malfunction and the product was not returned.A review of the lot history record and could not be conducted because the part and lot number were not provided.Myocardial infarction, pain and stenosis are listed in the xience v and xience nano everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that (b)(6) 2014 the patient presented with non-st-elevation myocardial infarction (nstemi).A 2.25x18mm unspecified xience stent and a 2.75x18mm unspecified xience stent were implanted in the circumflex (cx) artery.(b)(6) 2015 the patient presented with nstemi and three stents were implanted in the obtuse marginal: 2.25x28mm xience alpine, 2.25x28mm xience alpine, and 2.25x15mm unspecified xience stent.On (b)(6) 2015 the patient was symptomatic with arm and shoulder pain due to in-stent restenosis which was confirmed via angiography.Reportedly the patient had a renal transplant approximately three weeks prior to this incident and was told by the surgeon to stop taking medication.An asahi grand slam guide wire was advanced without resistance toward the restenosis in the cx and prolapsed.It was then noted via angiogram that the distal tip of the guide wire separated.The guide wire tip was free floating in the distal anatomy.The tip was deemed too far distal to retrieve, thus, no attempts were made to retrieve the separated portion of the guide wire.The proximal portion of the guide wire was removed from the patient anatomy without resistance.Ultimately, the stent restenosis was treated using balloon angioplasty, the patients arteries were open, and the procedure was ended.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; 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: 5271053
• MDR Text Key: 32804005
• Report Number: 2024168-2015-07323
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070015
• 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
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 4040241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• 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
• Treatment: STENT: UNK XIENCE
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 57 YR
• Patient Weight: 95