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

Catalog Number	1550325-23
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The additional nc trek device referenced is being filed under a separate medwatch report.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the balloon dilatation catheter causing the reported device damaged by another (balloon rupture).There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the procedure was to treat a heavily calcified lesion in the right coronary artery (rca).A 3.25x23mm xience sierra stent was deployed at an unknown pressure in the proximal end of the rca into the ostium.Post dilatation was performed with a 3.50x12mm nc trek balloon dilatation catheter at the proximal end of the stent in an attempt to flare the stent out into the ostium.The balloon was inflated to 18 and then 20 atmospheres.On the third inflation at 16 atm, the balloon ruptured and a dissection was noted.Another sierra stent was deployed overlapping the first stent as treatment.In the physicians opinion, the balloon material caught on the stent strut during inflation, causing the rupture and subsequent dissection.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.

• Brand Name: XIENCE SIERRA 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: 8663006
• Report Number: 2024168-2019-04297
• Device Sequence Number: 244940
• Product Code: NIQ
• UDI-Device Identifier: 08717648227356
• UDI-Public: 08717648227356
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2019
• Device Catalogue Number: 1550325-23
• Device Lot Number: 8120341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/03/2019
• 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: 3.5 X 12 MM NC TREK BALLOON DILATATION CATHETER
• Patient Age: 55 YR
• Patient Weight: 112