MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1012463-28

Device Problems Failure to Advance (2524); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: balance middleweight universal.Guide catheter: medtronic launcher.Though the device is not approved for sale in the u.S., it uses a delivery system which is similar to a device sold in the u.S.Evaluation summary: the device was returned for evaluation.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Based on visual and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.(b)(4).

Event Description

It was reported that the procedure was to treat a 90% stenosis in the diagonal branch of the left anterior descending artery with mild tortuosity and moderate calcification.The lesion was pre-dilated with a 3.0 x 12 mm non-compliant balloon.The 3.0 x 28 mm implant delivery catheter was advanced to the lesion, but was unable to cross the lesion.A 3.0 x 28 mm xience prox stent was used to successfully complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.The returned device analysis revealed a 4 mm tear in the shaft at the guide wire exit notch.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 5248106
• MDR Text Key: 32217177
• Report Number: 2024168-2015-07103
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P070015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Catalogue Number: 1012463-28
• Device Lot Number: 412186N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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