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

Catalog Number	1125350-33
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	02/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.The reported patient effects of angina and stenosis are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported stent break.Additionally, 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 or Problem Description
It was reported that on (b)(6) 2018, the patient presented with unstable angina and a 3.5 x 33 mm xience alpine stent was implanted in a tortuous lesion in the mid obtuse marginal coronary artery.Post procedure it was confirmed that the patient was compliant with dual antiplatelet drug therapy.On (b)(6) 2019, the patient was re-admitted with angina for a second percutaneous coronary intervention.In-stent restenosis of the stent was identified; however, during review of the stent implant under fluoroscopy, a stent fracture was also suspected.The suspected fracture was at the middle of the stent implant, at the site of the restenosis.Following de-bulking of the lesion with a laser, a 3.5 x 15 mm xience sierra stent was deployed to treat the restenosis.Post dilatation was performed with a 3.75 x 8 mm nc trek balloon dilatation catheter to complete the procedure.The patient was reported to be doing well post procedure.No additional information was provided.

• Brand Name: XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8445707
• Report Number: 2024168-2019-02264
• Device Sequence Number: 2170584
• Product Code: NIQ
• UDI-Device Identifier: 08717648199561
• UDI-Public: 08717648199561
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2019

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 Catalogue Number: 1125350-33
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/22/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR