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

Catalog Number	1125400-23
Health Effect - Clinical Codes	Angina (1710); Perforation (2001)
Date of Event	03/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.However, angina and arterial perforation are listed in the xience alpine everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a 70% stenosed mid left anterior descending artery.Rotational atherectomy was performed with a 1.75 burr.A 3.75 x 15 mm nc trek balloon catheter was inflated to 18 atmospheres for pre-dilatation.A 4.0 x 23 mm xience alpine stent was deployed at 12 atmospheres.Post-dilatation was performed with a 4.5 x 12 mm nc trek balloon catheter to 14 atmospheres when a perforation occurred in the middle of the stent.The patient had been having chest pain since the use of the atherectomy catheter; however, the pain increased after the perforation.The 4.5 x 12 mm nc trek balloon was advanced again and inflated to a low pressure two times for a minute each time which sealed the leak.A 3.5 x 19 mm graftmaster covered stent was implanted inside the stent to prevent future re-opening.The graftmaster was post-dilated with a 3.75 x 12 mm nc trek to 12 atmospheres and a 4.4 x 12 mm nc trek to 8 atmospheres to successfully complete the procedure.There was no clinically significant delay in the 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: 6402638
• Report Number: 2024168-2017-02102
• Device Sequence Number: 18965067
• Product Code: NIQ
• UDI-Device Identifier: 08717648199639
• UDI-Public: (01)08717648199639(17)191013(10)6101041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2019
• Device Catalogue Number: 1125400-23
• Device Lot Number: 6101041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2017
• Initial Report FDA Received Date: 03/14/2017
• 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: BALLOON: NC TREK 4.5X12
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 55