MAUDE Adverse Event Report: ABBOTT VASCULAR RX PRIME; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1011710-23

Device Problems Break (1069); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a 90% stenosed, moderately tortuous, and moderately calcified de novo lesion in the left anterior descending coronary artery.During advancement of a 3.5x23mm xience prime stent delivery system (sds) into the guide catheter, a kink was observed in the proximal shaft.During removal of the sds the shaft broke but remained in one piece.The procedure was successfully completed with a non-abbott stent.There was no clinically significant delay in the procedure and no adverse patient sequela.The shaft separated into two pieces during packing of the device for return.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported deformation due to compressive stress/kink was able to be confirmed.The reported break was unable to be confirmed; however there was a noted hypotube separation.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 other similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement inadvertent mishandling resulted in the reported/noted bends and kinks (hypotube, outer member, inner member, support mandrel).The reported break/noted hypotube separation occurred due to handling during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: RX PRIME
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9419399
• MDR Text Key: 177785083
• Report Number: 2024168-2019-14206
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2022
• Device Catalogue Number: 1011710-23
• Device Lot Number: 9012441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LAUNCHER GUIDE CATHETER
• Patient Age: 74 YR